An Insight Into Prophecy: Infallibility Essay

Plato once remarked that a community could produce its ideal leader and guide by handpicking a select few and exposing them to an intricate balance of gymnastics and classical music. Apart from the emasculating effect of such a course of action, it no doubt falls short of the prophetic paradigm. Prophets are an important vehicle by which Allah (swt) guides mankind; their task is to convey God’s will and provide an example worthy of emulation. Yet, in order to be emulated they must themselves be of an impeccable character. In this brief article, I shall approach the topic of prophethood from the gateway of infallibility and attempt to assess, through a discussion of the purpose of prophethood, why infallibility is required. In order for the discussion of infallibility to be a fruitful one, it would seem most appropriate to begin by shedding light upon the institution of prophethood. The religions of the world have venerated those that they consider to be prophets. These charismatic figures have led communities and shaped subsequent history. Such influence and prestige appears to derive from their common claim; that they are divinely inspired. Their popular appeal thus stems form the fact that they represent one of the many ways by which God manifests His immanence; that God is closer to us than our jugular veins.1 Yet, beyond this link with the divine, religions have differed, in some respects, regarding prophethood. Prophets, as characterised by Judaism, the first of the three Abrahamic faiths, were people who felt very deeply. They were devastated by the suffering of those that were oppressed. Having great resonance with the life of our final messenger, Muhammad (s.a.w), the Jewish prophets tended to have three main phases to their lives; contemplative seclusion, scathing criticism of the status quo and finally the provision of a means to salvation. And yet, when reading the Old Testament, it becomes very much apparent that the prophets were not of an impeccable character; they appear fallible and at times guilty of serious sin. The Genesis account of Jacob tricking his father Isaac is a particular case to note.2 Another conspicuous difference is that of ethnicity. Israel was Yahweh’s chosen nation, and as such, prophets, divine favours, were sent to guide them. In contrast, the Islamic prophetology is a universal one; it recognises both that â€Å"to every nation is a guide†3 and that Muhammad (s.a.w), the seal of prophethood, was sent as a â€Å"mercy to all the world.†4 In Christianity can be seen an even greater departure from Islam’s prophetology. Here, prophetology becomes theology in the act of deifying Christ. As a footing, aiding our understanding of the alternate prophetologies of these two faiths, we may compare what have been taken to be the respective symbols of Christianity and Islam; the cross and the crescent. Placing aside the inherent defects of redemption, original sin and the act of deifying Christ, it would seem that the cross, in Christianity, represents the one, single and unique redemptive transection between the transcendent and immanent God; the Father’s horizontal loftiness is brought to earth by Jesus’ vertical sacrifice. On the other hand, the crescent, suggestive of cyclicity and renewal, is an apt symbol of Islam’s prophetology; seeing successive prophets as one of a chain of 124,000 guides sent by the Almighty. As one is extinguished, another is born. The Islamic prophetology is conceptually simple. Islam views all prophets as having a common aim; preaching the message of monotheism. In the Qur’an, great stress is laid upon the figure of Abraham (a.s.) He is given due respect as the great patriarch; father to the line of Isaac (a.s) and Ishmael (a.s), and as such represents an ideal, that of Islam, from which Rabbinical Judaism and Pauline Christianity departed: Abraham was not a Jew nor a Christian but he was an upright man (hanif), a Muslim, and not one of the polytheists5 Along the model set by Abraham, famously known to be the slayer of idols, a line of great prophets descended. The story of Yusuf (a.s), Abraham’s great-grandson, referred to in the Qur’an as ‘the best of narratives’,6 provides us with a glowing example of how tawhid manifests itself in a believer; Yusuf (a.s), even in times of great tribulation had firm tawakkul, absolute trust in Allah. Even in jail he did not lose sight of his mission. Indeed, when asked by his two jail-mates to interpret their dreams, he ceases the opportunity to begin preaching to them, in wonderfully eloquent prose, of God’s oneness, and their ultimate accountability before Him.7 In spite of such archetypes, the children of Israel on many occasion defied their prophets. The Qur’an gives many an example of such defiance and the resulting divine retribution. The end product was that Rabbinical Judaism became fraught with legalism, and the spirit of faith began to fade. This was to contrast with the esoteric teachings of Moses (a.s), to whom the burning bush spake.8 The Qur’an also presents Jesus (a.s) as a worthy apostle who vehemently denies claims that he is God. The very first words of the Qur’anic Jesus (a.s), uttered in the cradle to defend his mother from charges of unchastity, form both a rebuttal to Pauline Christianity and concisely capture the Islamic prophetology: Surely I am a servant of Allah; He has given me the book and made me a prophet.9 Hence, in Islam, a prophet is simply a messenger of God sent to guide his people to the right path. The practical side of prophecy is that of responsibility; a responsibility by the people to follow the prophet. Regarding the final and most honoured of the prophets, Muhammad (s.a.w) the Qur’an says: Take what the Messenger gives to you, and refrain from what he prohibits you.10 It is from this platform that we may make the relatively straightforward leap to infallibility. Many arguments, both rational and scriptural, abound regarding the infallibility of the prophets. One of the most convincing is the argument that builds upon our responsibility towards prophets, as noted, and the subsequent paradox of following an errant prophet. M.R Muzaffar elaborates upon this argument: The reason for the infallibility of a prophet is that if he commits a sin or mistake, or is forgetful or something similar, we have to chose between two alternatives: either we obey his sins and mistakes, in which case, in the view of Islam, we do wrong, or we must not obey the his sins and mistakes, which too is wrong, because this is contrary to the idea of prophethood where obedience is necessary; besides, if everything he says or does has the possibility of being either right or wrong, then it is impossible for us to follow him. The result is that the benefit of his mission is lost; it becomes unnecessary, and the prophet becomes like ordinary people whose acts and speech do not have the excellent worth that we seek, with the result that there will be no obedience and his actions will be unreliable.11 ‘Allamah Hilli (d.1325), the twelver Shi’ite theologian of the Il-Khanid period, cites another key rational, aqli, proof for infallibility. He points to the argument ad infinitum; if the guardian is not infallible, then we are left with the indefinite question of who guards the guardian?12 Having provided but a taster to the arguments in favour of infallibility, one needs clarify what exactly we take it to mean. Muslim theologians have united doctrinally in favour of prophetic infallibility, and yet differences are noticeable in both its extend and its duration. Fakhr al-Din al-Razi (d.1209), a Shafi’i jurist and theologian of the Ash’ari School, claims that infallibility occurs only in the domains of belief, transmission of the divine message and religious judgement. This however, appears to severely limit the extent of authority accorded to the prophet, who is the example par excellence in all domains. Though al-Razi claims that the Sunni Ash’arites had agreed upon this, it appears that al-Baqillani (d10.13), another Ash’arite theologian, believed that the ‘infallible’ may commit unintentional errors in the transmission of the message to mankind. The flaws of such a view are clear. ‘Allama Hilli, whose views remain those of orthodox twelver Shi’ism to this day, provides a watertight definition of ‘isma, infallibility. He begins by explaining that infallibility does not itself negate the prophet’s ability to commit sin;13 avoiding sin is an active choice. This is in contrast to the determininstic understanding prevalent amongst the Ash’arites. Further, he stipulates that the infallible must neither commit grave or minor sins, in any domain, either before or after his mission commences.14 He reasons that a person who becomes inerrant upon being made a prophet will not have acquired the necessary respect from his people. Only a person that has been of exemplary character throughout his life can take on such a great responsibility as that of prophethood. In sum, one may say, rather schematically, that prophetic infallibility is denied within the confines of Judaism, extended to that of a deity in Christianity, and defined downwards by orthodox Sunnism. And yet, upon reflection, it would appear that prophecy is a great burden. Indeed, the Qur’anic revelation is described as a ‘heavy word’15 that is sent down upon the Prophet Muhammad (s.a.w). It is only with impeccable character, fortitude and resilience that the prophets were able to welcome such a burden, and live up to the responsibility of guiding mankind. Such character can only be adequately captured in an understanding of infallibility that does not seek to atomise, either temporally or spatially, the lives of the prophets; inerrancy most truly encompasses all domains and periods of the life of a prophet. 1 Holy Qur’an 50:16. 2 Genesis 25-28. The Genesis account speaks of Jacob having an elder brother by the name of Esau. Isaac had intended to bless his elder son before he died, but Jacob, aided by his mother Rebekah sought to trick Isaac into giving Esau’s birthright to Jacob. 3 Holy Qur’an 13:7. 4 Holy Qur’an 21:107. 5 Holy Qur’an 3:67. 6 Holy Qur’an 12:3. 7 Holy Qur’an 12:36-42. 8 Holy Qur’an 20:9-14. 9 Holy Qur’an 20:33 10 Holy Qur’an 59:7. 11 Shomali, S.A. Shi’i Islam, ICAS (2002) (unpublished manuscript), p67. 12 ‘Allamah Hilli, al-Bab al-Hadi ‘Ashr, commentary by Miqdad ibn ‘Abd Allah al-Siyuri, Mashad (1989), p41. 13 Tusi, Nasir al Din, Kashf al Murad fi Sharh Tajrid al-I’tiqad, commentary by ‘Allamah Hilli, Beirut (1990), pp.341-342. 14 Op.cit. Al-Hilli, p124. 15 Holy Qur’an 73:5

A Separate Peace: Coming of Age Story

Coming-Of-Age Story Gene Forrester is the protagonist of a coming of age story in many ways. First Genes shift from ignorance to knowledge is pretty apparent. An ignorant Gene is led to the tree where he jounces the the limb causing Finny to fall. The knowledge of his evil deed and the loss of innocence because of it really launches Gene from childhood to adulthood. Genes shift from innocence to experience can be expressed by the very same situation. Gene lost his innocence when he jounced the limb of the tree and injuring Finny because of it. He now has experience of doing sinful deeds.What drove Gene to jounce the limb was perhaps to bring Finny down to his own level and make the two equal. The very thought causes Gene to become a little less innocent and a little more devious. Part of coming-of-age is having the experience of the consequences of doing bad things. Gene also experiences a shift from a false view of his world to a correct view. In the beginning of the novel Gene view s his world as being confined to Devon and that the war was not going to approach him for a long time. He soon realizes that the war is coming for him whether he likes it or not.Coming-of-age also means accepting the things you cannot change and trying make a positive experience out of it. When Gene realizes that Finny made up his â€Å"theory† about the war because he was denied entry to all of the branches of the military, his view of the war changes. His view of the war changes also because he had found out that Leper was about to face a discharge and he abandoned his post because of it. He now views the war as a very real thing. Idealism and realism are two ideas that Gene faces through the course of the novel.In the first few chapters Gene is idealistic. He unrealistically pursues the idea that Finny resents him for his superior academic ability. We figure out though that it is Gene who resents Finny because of his athletic ability and charm. The idea of crippling Finny to bring him down to Gene’s level causes him to make Finny fall. He now faces the real effects of his actions and has to come to terms with them. He also realizes that Finny was to pure of heart to resent Gene and Gene envied this great quality. Recognizing the harshness of the realistic world is part of coming-of-age.

Detecting Plagiarism

The results of the paper, Lab Courses Go Virtual, came back with 98% similarity of plagiarism. This result defiantly exceeds the maximum amount allowed in regards to plagiarism. If I were the student, I couldn’t look my instructor in the eye or in this case respond to any correspondence with a clear honest and complete reason as to why I would have done something so deceitful as to copy some else’s work. My course of action toward the student would the following: I would like for you to understand that plagiarism reduces your self-confidence as a student. Clearly the paper that has been submitted was not your original work. Using some else’s work is not only fraudulent, but it promotes a lack of writing skills that is necessary in the workplace. Please review the universities guidelines on plagiarism. The guidelines are located: * Under the Library Tab * click Center of Writing Excellence located on the left hand side under * Writing Tools click Tutorials and Guides. * Under Plagiarism Tutorial click Plagiarism Guide. Keep in mind that I am here to assist you succeed in your journey. I encourage you to resubmit the assignment, within the four day time period from which it the assignment is due. At which time if you have not resubmitted the assignment in the time allotted, I will then assume that you have read the Plagiarism Guide and understand you will have failed the assignment and this course. There is also a possibility that you could be suspended from the university. I look forward to you resubmission of the assignment and if you have a questions or concerns please do not hesitate to contact me at [email  protected] phoenix. edu or call (509) 710-3537 anytime I will be happy to help.

Virginia Woolf Essay Example | Topics and Well Written Essays - 1250 words

Virginia Woolf - Essay Example The Hours are novels that represent life as it truly is rather than the way that society demands it should be and this is a theme that will be discussed in this paper. Mrs. Dalloway is a story that has as its main focus life in Britain during the interwar period and it attempts to deal with issues that individuals in this society were not willing to talk especially in public. Among the issues that were taking place in this society, yet nobody was willing to address is the existence of homosexual and lesbian relationships. These were issues which were hardly ever addressed in the relatively conservative society of Britain during the first half of the twentieth century and it created a situation where such relationships were often looked down upon. The same situation occurs in The Hours where while there has been considerable progress since the time of Mrs Dalloway, where the so-called non-traditional relationships were hardly ever recognized, Cunningham addresses the new issues that have become a reality in the modern world, specifically HIV and AIDS. Cunningham uses Richard, a prominent writer who has just won an award and suffers from AIDS, to pe rsonify the manner through which individuals in the modern society have come to suffer from this disease. One would argue that it is through the characterization of Richard from Clarissa’s perspective that Cunningham comes to inform the reader of how while the modern world may have accepted homosexuality, it has yet to come to terms with AIDS. The myths and stigma that are attached to this condition seem to be the cause of the depression that Richard seems to be suffering as seen through his not being excited about the party that Clarissa is preparing for him for winning the award. When one compares Mrs Brown’s character in The Hours with that of Mrs Dalloway, one will find these characters to be very similar. One would argue that this is mainly because they both seem to be unsatisfied with the life that they are

Sustainable relationship Marketing Assignment Example | Topics and Well Written Essays - 6000 words

Sustainable relationship Marketing - Assignment Example It transcends the boundaries between specialist functions and disciplines.† Gummesson (1999:73). Relationship marketing is closely intersected with sustainability – â€Å"a form of development that meets the needs of the present without compromising the ability of future generations to meet their own needs† (Benn & Martin, 2014:742). Nowadays, the role of RM is recognized by many different organisations, operating in various industries. Increasing number of organisations strive to focus on customer retention, to emphasize customer service, to maintain high contact with customers, and to pursue long-term relationships (Christopher, Payne, and Ballantyne, 1991). Relationship marketing is viewed as a multidimensional discipline, which has many different models applicable to various situations. Five major models discussed in this report are: (1) Relationship Marketing’s Six-Markets Model; (2) Sustainable Marketing Model; (3) Ethical Relationship Marketing Model ; (4) The Morgan-Hunt Model of Relationship Marketing; and (5) Return on Relationship Model. Combined use of these five models enables to understand various aspects of relationship marketing, interrelationship and connection of different elements. A company implementing RM strategy gains increased opportunities for retaining existing customers and build profitable long-term and sustainable relationship. In order to test this hypothesis, there was chosen McDonalds Corporation for further analysis. The research shows that initially McDonalds has made a focus on customer-centric approach early before the concept of relationship marketing has gained wider popularity. However, by 1990s the company has failed to ensure excellent customer service and value-added approach because of quick geographical expansion of its restaurants. However, soon the company has recovered its position on the market by developing comprehensive relationship marketing strategy, focusing on three major markets: customers,

Men & Women viewed differently Essay Example | Topics and Well Written Essays - 1000 words

Men & Women viewed differently - Essay Example You lookin' good in them shorts but they look better on the floo'1. It took me about three or four attempts to get the lyrics down, because partly it was heavy slang but part of it was, it was hard for me to believe that what was being said was actually being said. I thought to myself, well, it is a prostitute obviously to whom these lyrics are being addressed to, so perhaps there is some justification there. But in order to be fair to this project. I decided to get the country music video to view as well. I thought perhaps to be fair to the project, I should get a country music video which had a depiction of prostitute, but unfortunately I was not able to get any. I was able to get a Music Video by Shania Twain called "Any Man of mine". I must say if I was expecting a toned down conservative video where there is just singing interspersed with romance, I certainly did not get that. The music video was extremely sensual. The lyrics were most interesting. "This is what a woman wants ,A ny man of mine better be proud of me Even when I'm ugly he still better love me And I can be late for a date that's fine But he better be on time Any man of mine'll say it fits just right When last year's dress is just a little too tight And anything I do or say better be okay When I have a bad hair day And if I change my mind A million times I wanna hear him say Yeah, yeah, yeah, yeah, yeah I like it that way"2 . I thought to myself, if more men followed this advice they would not have a problem with relationships at all. However this was a music video. The sensual depiction of Shania Twain, dancing in her famed midriff did not suggest that she was dancing for just her guy. However it was interesting the contrast the implied usage of ugly. Now in Nelly's music video, the women were fairly decent looking and Shania is also very beautiful. But in the Hip Hop video, it was Ok to be treated badly, because you were ugly, while in the Country music Video. It did not matter if you were ha ving a bad hair day or did not look as pretty or cook as good; you were going to be treated like a princess. The difference between depiction of Woman in Country videos and Hip Hop Music videos was of a very deep nature. Now the Country music video also had a very sensual depiction of a woman. But this was a woman in control of her sensuality. There is here a woman's right to sexual self determination.3 There is no doubt in anybody watching this video that the person in this music video is somebody who is proud to be a woman and considers her sexuality an integral part of her. On the other hand, watching the Hip Hop videos, I did not get that feeling. It almost looked like that the women's appearance and existence on the video depended on what men thought of them. Even if the Women were insulted and apparently portrayed in what I would consider very demeaning. I thought I might do some research in who these women were who were in this video. It turns out most of these women in these videos are general junior artistes who are very often unpaid4. Now I would imagine if you were to be insulted and depicted so badly, you at least would want to be compensated for that. There is no question that a person watching Shania Twain's music video would have some difficulty of male responsibility and monogamy with her sensual

Corporate social responsibility (with an example) Research Paper

Corporate social responsibility (with an example) - Research Paper Example It is not right to say that Corporations are excluded from societies; they are part of it and hence have a role to play within in the society circle. It is the society which gives them the name and recognition, and in return there is much to be given back to the society as well (Asongu, 2007). A society could be broad in the spectrum like an oil company whose impacts are there for entire environmental system, similarly a society could be small like for a grocery store whose items are only benefited to the specified group of people. Hence Corporations are part of societies and to survive in business they have to understand the societal norms and responsibilities (Horrigan, 2010). Analysis based Point of Opinion According to scholarly literature, it can be indicated that corporate social responsibility is a modern concept and has been compiled from various definitions. According to modern literature, corporate social responsibility is a business norm that includes all the business comp onents in one domain, like it includes buyers, consumers, share holders, employees, and communities which have to be served in one system (Asongu, 2007). Hence CSR is a broad concept, a concept that reaches out to each component attached to its system (Asongu, 2007). ... In Worlds tropical regions like South Africa and North India, there have been infectious disease spreading, like malaria and leishmaniasis for which there is no cure provided just because of high poverty and fewer paybacks to the pharmaceuticals (Hirsch, 2008). On the other side, there are no cures for chronic diseases (tuberculosis) as pharmaceuticals have forgotten the moral responsibility and have prioritized wealthy attainments than society. The cures are there but the will is not and due to economic reasons and not scientific, pharmaceuticals have stopped to research and develop. It is all because the priority is wealth and money, so the norms of society, virtuousness and morality have got disappeared in the tropical regions (Hirsch, 2008). From the modern perspective, it is not wrong to say that virtue and social responsibility are just matters of the book and scripture and not more than that. According to Lynn Payer (author of Disease-Mongers, 1992) medicine industry has been dominant due to several reasons, one of the main reason is disease mongering, a concept that brutally destroys the notion of corporate social responsibility (Dossey, 2010). In the modern system, medicine industry (pharmaceuticals) generates more than one trillion dollars each year. One of the secrets for such dominating figures on revenues is disease mongering â€Å"expanding diseases and developing the demand† (Dossey, 2010). Out of the trillion, billions are spent on advertisement and marketing campaigns, which is all to bring response and acceptation from the customer. One harsh fact is that patients are customers, customers that bring demand for the industry. Hence it is not harsh to say that the system of 21st century itself is violating the

Fiji's relative global economic development Essay

Fiji's relative global economic development - Essay Example Till the 1980s, the descendants of Indian laborers that the British had brought on the islands dominated the country. Since 1987, the islands have faced a number of military coups that have disrupted attempts to form a democracy. The 1990 constitution of Fiji strengthened the powers of the native Melanesian community over the political scenario although an amendment in 1997 gave equal powers to the Indians and the natives. However, political turmoil has continued in the islands resulting in disturbances in the economic activities of the population and trade relations with the rest of the world (CIA). Fiji had an estimated population of 918,675 in 2007, of which 30.9 percent is below 15 years of age, 64.7 percent between 15 and 64 years and 4.4 percent above 64 years (CIA). 54.8 percent of the population are native Fijians, mostly Melanesian and Polynesian mix, 37.4 percent Indians and the remaining 7.9 percent others comprising of Europeans, other Pacific islanders and Chinese. About 92 percent of the Fijian population is literate (Bank of Hawaii, 1998). Fiji is richly endowed with natural resources, with forest, fish and mineral assets and is among the most developed among the Pacific Ocean islands. Yet, the economy of Fiji is still dependent on revenues from sugar export, tourism and remittances from Fijians abroad. 8.9 percent of Fiji's GDP of $2.033 billion in 2007 was accounted for by agriculture, 13.5 percent by industry and 77.6 percent by services, mostly tourism. One third of Fiji's industrial activity is related to sugar but processing of sugar is inefficient. Fiji exports most of the sugar output to Europe and may be hit by proposed subsidy cuts on sugar by the European Union. Tourism has also been affected by the repeated coups in the country. The Reserve Bank of Fiji anticipated a contraction of the economy by 3.1 percent in 2007-08 (CIA) and a runaway current account deficit, which was 23 percent of GDP in 2006. Relative Economic Development and Concerns Fiji ranks 92nd in the Human Development Index (HDI) and in terms of per capita Gross Domestic Product at Purchasing Power Parity, with $6,049 and 108th in terms of life expectancy at birth, which is 68 years (HDR). In 1998, Fiji ranked top of the World Bank's list of lower-middle income group countries and was in the same category as Latvia, Peru, Lebanon and Costa Rica (Bank of Hawaii, 1998). However, political instability and lack of industrial activity have resulted in some contraction of the economy since then. Fiji is a small country, slightly smaller than New Jersey. The economy is also far smaller than the United States. The per capita GDP at official rates in Fiji in 2007 was $4,100, less than one-tenth of what it was in the US, at $46,000. Life expectancy at birth in Fiji, at 68 years, was also lower than in the US, 78 years. Population below the poverty line in Fiji in the last estimated year, 1990-91 was 25.5 percent and the unemployment rate was 7.6 percent. On the other hand, only 12.4 percent of the population in the US was below the poverty line in 2004 and the unemployment rate in 2007 was 4.6 percent. Fiji exports primary products, mostly agricultural to the US and Europe, and imports manufactured commodities. The major concern for the Fijian economy is the political uncertainty that the islands have been facing over the last two decades. This has resulted in

Report on Ryanair and British Airways Essay Example | Topics and Well Written Essays - 3000 words

Report on Ryanair and British Airways - Essay Example 334). With the message â€Å"To fly. To Serve.† British Airways has access to almost 169 different destinations in the world. Ryanair When the aviation industry of Europe went into the phase of deregulation in the late 1990s, Christopher Ryan, Liam Lonergan and  Tony Ryan’s infant Ryanair received just the opportunity that it was looking for to make an impact on the global aviation industry (Schein, 2006, p. 41). Following the model of Southwest Airlines, Ryanair has also been able to replicate the success enjoyed by Southwest. The company now flies to more than different destinations and posted revenue of over 4.3 billion Euros for the year 2012. Important here to note is that Ryanair is a low cost budget airlines and follows a Southwest model, whereas, British Airways has refrained from doing the same (Purcell, et al., 2004, p. 214). Organisational Culture and Organisational Structure and Design There is empirical evidence which conclusively suggest that strong orga nisational culture and organisational structure have the potential to provide stability to organisations. In fact, certain organisations, over the years, have been able to outclass their competitors and withstand the pressures of globalisation, competition and macro environmental forces, primarily, because of their strong organisational culture or suitable organisational structure. Organisational culture plays a boundary defining role (Mills, et al., 2006, p. 334; Purcell, et al., 2004, p. 214). In other words, it draws a clear line between the organisation and others, thus, creating an â€Å"us versus them† feeling amongst the employees to motivate them to work for the goals of the organisation (Purcell, et al., 2004, p. 115). Organisational structure, on the other hand, refers to the patterns of relationships and interactions within the company. The greater the individuals within an organisation have to communicate and interact; the greater becomes the need for finding an a ppropriate and suitable organisational structure and design for the organisation (Griffin & Moorhead, 2009, p. 74; Cunliffe, 2008, p. 75). Outline of the Paper This paper is an attempt to explore and analyse the organisational culture and organisational structure of British Airways and Ryanair, the two giants of the aviation industry in Europe. Not only the paper would comparisons between these two organisations but relevant theoretical material would also be used to analyse the suitability and relevancy of the organisational culture and structure of these organisations. Discussion Organisational and Structure and Design at British Airways and Ryanair It was during the year 2008/09 that British Airways made it apparent to the world that it wants to reinvent the organisational structure and restructure the hierarchy to make a much leaner, agile cost effective and responsive organisational structure. British Airways realised that in the times marked with European Sovereign Debt Crisis , global economic meltdown, financial crunch, decreasing consumer confidence and recessionary pressures, it is almost impossible to survive within the highly competitive airline industry in the absence of taking more radical steps (Tosi & Pilati, 2011, p. 574). However, the organisation also realised that in order to make changes at the organisational level, they would have to start at the top and begin this change from the top

Examining a Bussiness Failure Research Paper Example | Topics and Well Written Essays - 1000 words

Examining a Bussiness Failure - Research Paper Example The present study would try to analyse the organizational behaviour aspects that could be interrelated with the company’s failure in the recent years. This would include an analysis of the aspects of management, leadership as well as organizational structure towards the unfolding crisis that occurred in the organization. Leadership Leadership is perhaps one of the main drivers of a business. A business essentially thrives on the aspect of the vision of the leader of the organization. One of the main reasons for the crisis situation at Enron can be held accountable to the improper leadership of the organization. The lack of proper vision of the company’s leadership can be traced to the fact that its CEO Jeffrey Skilling resigned from the company that was just beginning to see the light of the crisis situation. Another interesting fact was that the CEO while putting down his papers did not cite reasons for resignation which reflected the negative mindset and lack of leade rship skills of the leader of the organization (Jickling, 2002, p.2). An effective leader in this case could have saved the organization from the crisis that has led to the eventual downfall of the company. An effective leader should have realised the malpractices in the company and should have taken corrective measures and should have displayed visionary traits that could have saved the organization. The role theory of leadership states that leaders must act in a manner so as to set goals for others (Changing Minds.org, 2011). The case at Enron reflects a bad picture as the leader displayed complete lack of responsibilities as he left the firm when it was in the midst of a severe crisis and set a very bad role example. Management The management of an organization comprises of the top management board including the top shareholders and the top executive management of the company. The poor state of management of the organization can be easily identified from its actions as the top ma nagement reflected its existence only on paper. The management indulged in corrupt malpractices that ultimately led to the downfall of the organization (Worldlink, 2007, p.2). The top management of the organization defected from its basic responsibility of ensuring compliance in corporate management in an attempt to protect the interests of the existing shareholders of the firm. The top management showed a complete mismanagement as it allowed the CFO of the organization to allow him to do private based partnerships for undertaking business with the organization that was largely against the basic rules of corporate governance. The management of the organization was largely selected through internal preferences where the executive management had a final say. Independent directors largely acted as puppets of the top management of the organization that largely defeated the basic purpose of having independent directors on the board of an organization. Enron should have followed the corpo rate governance ethics and the management should not have been allowed to have a say on the appointment of independent directors. If the company had adopted a democratic and impartial selection of the independent directors, then the malpractices would have been identified long before and would have

DQ Week 8 (Managing Professionals) Essay Example | Topics and Well Written Essays - 250 words

DQ Week 8 (Managing Professionals) - Essay Example This is part of man’s humanity. On the other hand, if the situation only aims to unite people towards a common goal or inspire them, then transformational leadership is most important because it would take time to see the fruits of this kind of leadership. Yes, I have. As there is no formula for authentic leadership (George, B., Sims, P., et. al., 2007), I think I have managed to observe several authentic leaders. An example of authentic leadership that is close to home would be my teachers at school. One of the traits common in leaders interviewed in a survey (George, B., Sims, P., et. al., 2007) is that they tap into and hone their strengths and skills in order to influence to others to become better people and this is what my teachers do for me. They guide me with their knowledge and help mold me into the person I am. Aarons, G. (2006). Transformational and Transactional Leadership: Association Toward Evidence-Based Practice. Psychiatr Serv., 57(8). Retrieved from

Organization Behavior Essay Example for Free

Organization Behavior Essay âž ¢ Anne Mulcahy at the age of 23 she was the director of human resources, head of the Xerox âž ¢ She spent her first 16 years companys fledging desktop computer business, and chief in sales, then eight years in an assortment of management of staff to Xeroxs CEO. âž ¢ She never aspired to run Xerox nor she was groomed to be CEO. In 2001 she became the CEO of Xerox. âž ¢ She accepted the position when the company was in horrible financial shape. It had $17.1 billion in debt and only $154 million in cash. It was about to begin seven straight quarters of losses. âž ¢ Mulcahy felt a deep loyalty to the company. She felt an obligation to do everything in her power to save Xerox. Duty and loyalty compelled her to take a job that nobody else really wanted, despite the fact that she had zero preparation. âž ¢ She didnt know financial analysis. She had no MBA and her undergraduate degree was in English/journalism. So she asked the companys director of corporate finance to give her a cram course in Balance Sheet 101. He helped her to understand debt structure, inventory trends, and the impact of taxes and currency rates. âž ¢ This allowed her to see what would generate cash and how each of her decisions would affect the balance sheet. Mulcahy says now that her lack of training had its advantages. She had no preconceived notions, no time to develop bad habits. âž ¢ She appealed to employees with missionary zeal, in videos and in person to save each dollar as if it were your own. In 2002, for instance, she gave all employees their birthdays an off. The gentle pressure was vintage Mulcahy: Work hard, measure the results, tell the truth, and be brutally honest. âž ¢ After less than two years as CEO, Mulcahy has made startling progress in turning Xerox around. Employees appreciated her truthful and straightforward style. They also liked the fact that she was willing to work shoulder to shoulder with subordinates âž ¢ She was working hard, people felt obligated to work harder too. But Mulcahy is no softy. Shes smart, energetic, tough but passionate. âž ¢ She showed the ability to make hard decisions. For instance, she slashed costs in part by cutting Xeroxs workforce by 30 percent and she shut down desktop division. She oversaw the streamlining of production, new investment in research and development, and restructured the sales force so vague lines of authority became clear. She met with bankers and customers. âž ¢ In 2003, Xerox had had four straight quarters of operating profits. The companys stock was up to $11 a share. And while Xeroxs future was still far from secure, at least it was beginning to look like the company would have future. 1. How did Anne Mulcahy create trust with employees after becoming CEO? âž ¢ We see that Anne Mulcahy is the ultimate loyal employee in Xerox. She represented herself as a Savior who would deliver them from the storm though she didn’t have any vision nor she was trained but she was determined in doing her task. Duty and loyalty compelled her to take a job that nobody else really wanted. âž ¢ Though she didn’t have any knowledge in financial aspects she learned in the short span of time and took initiative to cut costs by using strategies like reducing the work force, which was a smart move of cutting cost, and she restructured sales force, etc. âž ¢ She appealed to employees with missionary zeal, in videos and in person to save each dollar as if it were your own† âž ¢ She believed in these words that it is an era to work hard, measure the results, tell the truth, and be brutally honest. âž ¢ That is how employees, appreciated her truthful and straightforward style. They also liked the fact that she was willing to work shoulder to shoulder with subordinates 2.Did Mulcahy have a vision for Xerox? Explain. Anne Mulcahy had no vision or any aspiration to run Xerox. We can see this as initially when the Xeroxs board chose her as CEO of Xerox. She was neither groomed nor aspired for this position. But she accepted the position with a mixed feeling. She took the position when the company was dooming. She had a deep loyalty to the company and she realized her responsibility to save Xerox although she was not prepared. But she had a determination to save Xerox. 3. What qualities do you think helped Mulcahy to affect the turnaround at Xerox? âž ¢ Charismatic quality: She has an inborn quality to stand in any kind of situation that is a special quality of determination to serve her company. âž ¢ She also had inner qualities like self-confidence, Problem-solving ability. When she took the position of CEO the company was in horrible financial shape. A leader needs lots of self-confidence in such situation, which Anne Mulcahy had. âž ¢ She stood to save her company and sole the crisis. Mulcahy wasnt groomed for the CEO position is a true understatement. For instance, she didnt know financial analysis. She had no MBA and her undergraduate degree was in English/journalism. So she asked the companys director of corporate finance to give her a cram course in Balance Sheet 101. He helped her to understand debt structure, inventory trends, and the impact of taxes and currency rates. This allowed her to see what would generate cash and how each of her decisions would affect the balance sheet. Mulcahy says now that her lack of training had its advantages. She had no preconceived notions, no time to develop bad habits. âž ¢ Passionate: She was passionate in doing her work and also influenced others to follow her and she believed that employees should â€Å"Work hard, measure the results, tell the truth, and be brutally honest.† âž ¢ She also had other qualities like smartness, energetic, tough but passionate 4.What does this case say about leadership experience? Through this case we can see that Anne Mulcahy is a successful leader. Why a leader? Because she was a shepherd to her company leading her sheep’s. And Anne Mulcahy is said to be a leader as she lead her people to follow her. A Leader is an individual person who initiates and implements that is what Anne Mulcahy did. She can be called a Transformational leader as she implemented changes. For instance she slashed costs in part by cutting Xeroxs workforce by 30 percent and she shut down desktop division. She oversaw the streamlining of production, new investment in research and development, an restructured the sales force so vague lines of authority became clear. She met with bankers and customers. Most importantly, she traveled. She galvanized the troops visiting Xerox offices—sometimes hitting three cities a day—and inspiring employees. This is what matters as a leader to influence people to follow them. And she led her company from â€Å"rags to riches†

The Origins of Hip Hop | Essay

The Origins of Hip Hop | Essay 1. Introduction Hip Hop was born in the early 1970s amongst poverty and gang violence in the South Bronx. In the beginning of Hip Hop DJing, MCing, graffiti writing, and break dancing were used as a way to channel the energy of the youth in a more positive way. Thirty years later things have changed, the game is more serious. There is a lot more money involved, there is a lot more at stake, some say it is dead. If so, who killed it? (YouTube 2) In this essay I will look at the growth of Hip Hop as an art form, from its origins in New York through to its transition into the world wide phenomenon we are familiar with today. My main focus will be to explore and understand why so many people seem to be asking the question is Hip Hop dead?. In order to answer the question is Hip Hop dead? it is first necessary to define my understanding of the question. In this essay I will be evaluating the health of Hip Hop, not in terms of its popularity or the money it generates but in terms of its health as an art form: is it still a thriving, growing, developing form or has it stagnated under the weight of its own success? I will be looking at the artistic growth of Hip Hop as well as the effect that commercialisation has had. My essay charts the decline of the rawness that was at the core of Hip Hop in its early phase of development in New York City, when it was recognised and respected for its in the moment personal creativity, where the dancing would bounce off the music, the music off the rapping, and the rapping from the sounds of the streets. 2. The Origins of Hip Hop Hip Hop is an art form that includes rapping rap music, graffiti writing, particular dance styles (including break dancing), specific attire, and a specialized language and vocabulary. (Droppin science p224) To master an art in Hip Hop required a creative and expressive skill, whether it be a physical expression, rhythmical lyrics, vocal percussion, playing with the many aspects of music or graffiti art. Hip Hop is also a cultural movement which grew and developed primarily amongst poor black kids in the streets of the South Bronx, New York City, in the mid to late 1970s. These were young Afro-American kids, descended from slaves bought over from Africa in the 18th and 19th centuries who lived in poor social conditions: broken families, poverty, poor education, lack of any job opportunities and much radical prejudice, and police prejudice. They lived in black ghettos where violence, and death were common. In the same way as their recent ancestors had been enslaved and made to work the plantations of the Southern states in places such as Mississippi and Alabama, they also felt enslaved in a system which seemed to offer them no way out. America condoned the peculiar institution of slavery from 1619 up until the passage of the 13th Amendment to the Constitution which abolished slavery and involuntary servitude on December 18, 1865. (Bruno, Anthony (no date) [online]). When slavery was abolished in 1865 (Bruno, Anthony (no date) [online]), and the slaves were suddenly freed, the necessity to work and earn money to survive led them to emigrate to the richer Northern states of America, to cities such as Washington, Chicago and New York, where jobs were available, however low paid. As well as a large number of Africans moving to the Northern Cities, so did many Latinos who had originally emigrated from Mexico, and Puerto. The same attraction of a better life and a chance to make money spurred on their movement North. The Afro-Americans and Latino youth that grew up in the streets of these Northern cities, were the originators of Hip Hop. However, although Latino groups, particularly in New York, made a huge contribution to Hip Hop, there is no doubt that the main influences on Hip Hop came from the African American population. Lack of education and strong prejudice against African Americans led to the being stuck with the dead end, poorly paid jobs and these conditions led to a high level of crime and violence, particularly involvement of drug dealing. To many there seemed no choice, it was either poverty or crime. It is the frustration and anger created by these conditions, especially the lack of any opportunities to improve their situation, that gave rise to the birth of Hip Hop. Hip Hop became that way out, and the music and rhythms of their ancestors were reborn within Hip Hop. The ancient African tribal rhythms and musical traditions travelled with the slaves and remained an important part of the life of an African slave in America, and after 300 years of slavery in the so called Land of the Free the sounds of Old Africa became the new sounds of black America. Rapping, the rhythmic use of spoken or semi-sung lyrics grew from its roots in the tribal chants and the plantation work songs to become, an integral part of black resistance to an oppressive white society. (The roots of Hip Hop, online) Hip Hop, like its direct ancestor, the Blues, were both born out of social deprivation and the determination to use the experience in a positive way, and to escape the clutches of poverty. 3. The Development of Hip Hop YouTube Video 1 briefly shows an interview with a man on the streets of the Bronx, shot in 1986. He talks about how the music programs in the schools of New York would often cut out because of budget problems, and the only way for the kids in the schools to get music lessons would be to pay for them outside of school, which many could not afford. Hip Hop was a new form invented by the kids who struggled with money, and the place they would learn from was on the streets. They used the pieces of music from their roots, their blood, music influences such as blues, gospel and jazz to create a new genre. The genres which their ancestors would have known during the slave trade back in the South of America. A time of similar misery, and expression of the same pain and sorrow in their souls was being called out. For them there were many similarities with their ancestors. Hip Hop was something the youth could get excited about, and have a passion for. It was something that no amount of money or person could get in their way and stop them. And over the few years, whilst not only was Hip Hop gradually developing as a music, dance and art form, so was their range of listeners. More and more people outside of New York were becoming familiar with the genre, and soon an identity had been created for these youths. They had become what they had longed for, a something which was making an impact. Not only were the youth creating the music, dancing to the music but they were living the Hip Hop genre as a way of life. But not at the time were they aware of the size of impact they were going to have on the rest of the world. (YouTube 1, Dropping science 230) It was the disco DJs in the clubs where the roots of the Hip Hop music style began. An interest grew of paying attention to the blending of one track into the next one, as opposed to finishing one and the starting another. The DJs began matching tempos to make a smooth transition. The reaction from the crowds was nothing but excitement as they became witness to gradual build up beats and phases would suddenly put you into a whole new track. (P 12 The rap attack) At a similar time as DJs finding a new and exciting craze in paying attention with and playing around with the beats and tempos of tracks, originally MCing referred to today as rapping was being developed in the streets of the Bronx. Rapping is one of the main elements which had always been at the heart of the Hip Hop genre. It was seen as a skill of rhythmic talking over a funk beat. (P8 The rap attack) Lets Work Together It was not long until these new styled DJs and Rap artists would come together and put the two talents together for everyone around to hear. One of the first DJs to explore this collision was DJ Kool Herc in 1975, who is often referred to today as a godfather of Hip Hop. Another popular DJ at this time was Love Bag Starski, and was known as the first to refer to this new found culture as Hip Hop. With the fast development of rap in the early 80s, rap music records where being played everywhere around America. However in the Bronx the listeners were still excited about the beats of the records and soon became obsessed with what was known as the break of the records, where the lyrics of a track would stop and all that could be heard were the strong beats and rhythms from the drums. (P14 The rap attack) These breaks in the records would be what the listeners would be waiting for, and the dancers to do their thing. This response led DJs to open up their creativity as DJs. From just playing records from start to finish, they would use the breaks as their bass and play around with cutting, repeating, layering, using turntables, extending parts of the records however they wished and felt at the time. Their time of developing a creative identity came. Suddenly the chances of hearing one copy of a James Brown record did not exist. (P14 The rap attack) Around 1973, the new craze of longer lengths of the breaks was reflected in the longer length of improvised moves of the dancers. Soon a new name break-dancer was what these dancers started to call themselves, or b-boys and b-girls for short. The kids who were into the breaks started calling themselves B-Boys and the wild, acrobatic style of dancing which accompanied the playing of the breaks became known as breaking. The better Bronx DJs like Kool Herc, Afrika Bambaataa and Grandmaster Flash started mixing two copies of the same record to make the breaks last longer; (The roots of Hip Hop, online) This was when the dancers would be creating the moves that inspired the lay down of Hip Hop dance. (online, Hip Hop History) Bringing it Back to the Streets The vocal percussion called beatboxing, is known to have grown originally as an urban form. The beat box drum machines used to create the breaking that the more established MC and DJ artists were using, could not be afforded by the majority of the Hip Hop creators on the streets. Therefore if the breaks could not be made for them, then they would make the breaks themselves through the skill of beatboxing. These soon established beatboxers were imitating drum sounds and beat patterns using the lips, tongue, mouth, throat, and voice. Its summed up with the image of a guy in a hoodie with his hands cupped over his mouth spitting and making wonderful noises. (The Real History of Beatboxing: Part 2) Hip Hop Dance The gangs of the Bronx strongly influenced the development of the Hip Hop dance style. The gang experience and forced hard and strong persona they was almost required to be taken seriously among the streets can been seen of an influence in the dance of Hip Hop. More specifically the dance style uprocking. Before gangs were going into battle, it was known that they would perform a particular dance in order to get the adrenaline running and bring an aggressive nature to the surface. The gang members would carry out movements that would resemble actions that would take place in moments of violence with an enemy. The dance would consist of kicks and strikes between the dancers. (P229 Droppin Science) In the early days, Hip Hop dance was an outwardly body expression specific to that person and their feelings spurred on from the beats and rhythms in the music being heard. The style has adopted a large range of different skills which have developed over time. The dance includes breaking, popping, locking, and free styling, while its movements indulge jumps, breakages, and rotations. Such elements make this dance style amazingly explosive and truly informal. (Hip Hop Dancing) Hip Hop dance has received a renowned respect for being a genre which demands such a high level of personal creativity. Just like the musicians, the dancers develop their own identity to how they dance, and they cannot be wrong. Dance genres such as ballet, demands a specifically noticeable technical ability which normally requires years of intense training. Hip Hop however enables an openness that most genres do not, a freedom to move however you wish. The only requirement which can be seen is an understanding and respect as a creative culture. (Hip Hop Dancing) What made Hip Hop dance so interesting when being performed in the Bronx was the ability to see such a range of new moves, new ideas, new ways of expressing. However with Hip Hop dance today, in the music videos created in the money making world, how often do we see a range of creativity? In my opinion hardly ever. Sure the choreography might involve different steps, but it will almost definitely involve a focus on female dancers, carrying out a version of booty-shaking, torso popping and hair flicking. Moves which emphasises the woman figure and create a more sexual orientated atmosphere. There is no denying that the attention to the movement of the à ¢Ã¢â€š ¬Ã‚ ¦bum.. does not link back to moves that would have been found in African history, but Hip Hop in its original day was not all about just that. Just like how many more times can a Hip Hop artist swear in a song, how many more times can a Hip Hop dancer booty-shake? Not much more. Booty-shaking that existed originally as one of many Hip Hop moves has been taken and pushed forward to be portrayed as what Hip Hop dance is. The money making corporate world knows that sex sells, and to them the more sexy moves the better. Graffiti Graffiti is another of the main expressive elements that made up the Hip Hop culture. Graffiti represented the visual, emceeing and DJ produced the music, and B-Boying was the dance. In the early days of hip-hop, all of these elements were deeply intertwined. (graffiti and Hip Hop, online) Graffiti was normally an expression of the political activists in Hip Hop, people who wanted to mark their territory. Graffiti would be found all around the city, particularly on subways. People suddenly did not have to visit the Hispanic parts of the city to become face to face with the Hip Hop culture that was emerging, as graffiti was bought to them, a permanent reminded of the current sub-culture that was growing around them. The were adamant for their previously silent voices to be heard. Not long did graffiti progress from a scribbled tag (nickname) or club name on the wall to an elaborate art form emblazoned with Magic Marker and spray paint over every available surface of the subway trains and buildings. (P15 The rap attack) Competition Another element of Hip Hop that separates itself from other genres is how originally it would be performed in the form of a battle, whether it be rapping or break dancing. One side (or sometimes more) would go against another, and each side would take turns to show what they had to offer with a sort of you think your better than us, prove it attitude. This competitive nature stood at the heart of Hip Hop. Not only did it help displace violence and drugs such as heroin, but it also fostered an attitude of creating from limited materials. (P15 The rap attack). These young black men wanted to prove themselves to the world, and with these battles they were suddenly given a chance. I was ironic that these battles only ended up supporting the views of much of white America that young African American males are threatening, and that this then further restricted their entry into the mainstream service economy as well as other areas of mainstream life. (P229 Droppin Science) 4. The Social Impact of Hip Hop The most noticeable impact Hip Hop had on the community was the decrease conflict between the many established gangs that existed. It was within The Bronx and, to a lesser extent, Harlem that black youths developed their own alternative to the gang warfare that had risen from the dead in the late 1960s to dominate and divide neighbourhoods north of Central Park. (P12 The rap attack) The Savage Seven was the name given to the first known gang that took on the streets of the Bronx. This group of teenagers laid the groundwork for a surge of street gang activity that would overwhelm the Bronx for the next six years. One of the most well-known and influential originators of Hip Hop along with Eric B. and Rakim was Afrika Bambaataa, (more specifically in break-beat dee-jaying) is seen today the Godfather of Hip Hop Culture. Bambaataa, who was once himself not just a member but a leader of the Savage Seven, set up the group Zulu Nation, a Hip Hop group that spoke the message of factology versus beliefs. (Zulu Nation website, online] Hip Hop History) Zulu Nation spoke out of beliefs of right knowledge, right wisdom, right overstanding, right sound reasoning, to bring about right ways and actions. Bambaataa spoke out to the youths of Hip Hop with a message describing the importance of knowledge, wisdom and understanding. (Zulu Nation website) Zulu Nation effectively reached out to the large number of current gang members in the Bronx and show them a chance of an alternate path in life. The African American youths were able to express their frustration and pain now in a way which did not require violence, instead of putting it on one another; they were putting it into Hip Hop. A peacemaking was established. (Dropping Science 213) The school playgrounds, community parks and centres helped bring what were once gang enemies in the ghetto together. The former threatening gangs transformed into relatively harmonious, harmless crews, and the only battling they would have with one another was through the exciting new form of Hip Hop. The gang lives many Afro-American youths had, was never hidden away and ignored in Hip Hop. Instead, the pain and suffering they experienced bought to the forefront of much of the rapping creativity, as a chance to express how they really felt and not be rejected by it became an seized opportunity for many to release their inside emotions. An interesting description of the way Hip Hoppers reacted to media attention and the manipulation is in the book Droppin Science. William Perkins interview with a filmmaker and author of that time Michael Holman describes how the Bronx youth had created a cultural depth and confidence to talk back, when challenged by the media, staying loose, and reacting in a way which most likely spurred on even more attention to how strong the Hip Hop culture had grew to become, they stayed fresh, they maintained that certain volatility that Hip Hop craves. No fear of the end of the world, just fear of being stuck: If you became classifiable, Holman says, you became all the things that kept you in check. (P214 Droppin Science) Through Hip Hops deeply personal and expressive nature, whether it be through words, movement or art we are bought face to face with the reality of the suffering of the African Americans were experiencing at that time. Hip Hop stood out as a form which spoke of stories of everyday life experiences in the streets. (Hip Hops evolution, online) However any positive social impact from Hip Hop in the early days of its development was soon undone when the commercial pressures of the market started to take effect. 5. The Commercialisation of Hip Hop What does the term commercial mean?   It can take on various meanings, but in essence that term is used to label artists who have alienated parts of the hip-hop culture in their work.  (Hip Hop Culture Essay) There is no denying that commercialisation has helped to open up Hip Hop to the rest of the world. Originally Hip Hop was very much an Afro-American art form, however with the commercial world recognising and marketing the genre with music shows such as MTV, the audience range opened up not only to the whites of America, but the rest of the world. A world can now be said to be dominated by Hip Hop in a commercial sense, but perhaps no longer in an artistic sense. However, many people believe that commercial hip-hop has deteriorated from what so many emcees in the 80s tried to build a culture of music, dance, creativity, and artistry that would give people not only something to bob their head to, but also an avenue to express themselves and deliver a positive message to their surroundings. (Droppin Science) For instance, the dancers we see on TV in Hip Hop music videos and on stage with Hip Hop artists today might look like Hip Hop dancers and be able to do Hip Hop dance, but do they really have artistic integrity and spontaneous thrill of the originals danced on the streets of New York? Well, they are not creating the moves; most likely the steps are taught for them to copy and perform. There is little creativity or realness they learn and perfect their moves in studios, not the streets or in the ghetto clubs the realness in that sense is not in Hip Hop anymore. (mrwiggles, online) Also, Hip Hop music has become to rarely live anymore with many performers miming vocals to pre-recorded backing tracks. Thinking on the spot, being under pressure, being unpredictable and real in the moment as you do your thing, was one of the core skills originally associated with being a master of the form. How often today do we see the so called top Hip Hop artists of today think on their feet? Music videos are recorded, re-recorded, played with, special effected, deleted, you name it. We are hardly given the chance to see Hip Hop being presented as one artist showing what they can do, with the microphone, with the floor. The originators of Hip Hop did not just get involved in creativity and performance, they lived the Hip Hop lifestyle. But as soon as Hip Hop gained media attention and respect for its potential, it was not long until big business seized the opportunity to have a piece and shape the artists style in a way which they felt would make money. Vanilla Ice is a clear example of an attempt to change Hip Hop into a more poppy genre of music. Vanilla Ice was a white kid from Florida who was used to try and create a crossover between Hip Hop and pop music; a blatant and widely ridiculed attempt to manufacture a Hip Hop artist with mass appeal. Gangs were still involved in Hip Hop as it grew, and some believe that there was more gang involvement than ever before. We call them the Hip Hop record labels. They may not call themselves gangs, but through the extreme competitiveness of the record companies to be bigger and better than anyone else, the rivalry backbone still remains. The most famous and recognised record company rivalry is between the West Coast and East Coast. The West Coast record label Death Row founded by Dr. Dre and Suge Knight verses the East Coast label, Bad Boy founded by Puffy Combs. The website Knowledgerush says that the rivalry intensified as Hip Hop continued to enter the mainstream in the United States and abroad; more money entered the industry and raised the stakes. The focal point soon came to a head with Tupac Shakur on the west coast and Notorious B.I.G. (Knowledgerush, online) Tupac (West Coast) and Notorious B.I.G. (East Coast) were two talented rappers, who were friends and would occasionally see one another despite the competitiveness between their record labels. Both were murdered within six months of each in 1996 as part of feud between the East and West coast gangs. The obvious explanation behind the deaths of Tupac and Biggy is in the saying an eye for an eye, and was as a result of the rivalry between the record companies. However the most sinister theory fingers Knight for both murders, the founder of Death Row. (Hip-hop homicide, online) TAKE OUT When Tupacs body lay dead waiting for atomisation (autopsied), his infamous tattoos were fully displayed, including his signature phrase, thug life, in large letters in a semi-circle around his abdomen. (Knowledgerush, online) Despite Hip Hops development into a world full of money, the artists of Hip Hop were still living the Hip Hop culture, Hip Hop still remained their life. Many commentators were of the view that the feud between the East and West coast Hip Hop gangs and the deaths of Tupac and BIG were all primarily morivated by money. As the comedian Chris Rock said, when Tupac became worth more dead than alive, it was the end for him. (Bigger and Blacker, Chris Rock). Rivalry still exists today with Ja Rule verses DMX, Eminem verses Benzino and Jay-Z verses Nas. Not much has really changed. Mentioning and dissing of other gangs started to become a major lyrical theme within Hip Hop in the 1990s. MCs began incorporating more varied and stylistic speech, and focused on introducing themselves, shouting out to friends in the audience, and boasting about their own skills, and criticizing their rivals. (Knowledgerush, online) Not surprisingly this would result in their rivals feeling disrespected and seeking revenge. These Hip Hop artists would never work and travel as individuals, they would go around in big groups including others from their record labels, calling it an entourage. A direct link to the gangs that walked New York cannot help but be made. The bigger the entourage, the more of a successful impression they would make on the rest of the world. A genre that was originally aimed to help the stop gang violence in New York, over time has transform into a genre which can not help but seem creating violence, and glorifying gun culture. Hip Hop identity is now a world-wide phenomenon, the cutting edge of global youth culture. The gangsta identity both represents the drama of the streets, but also the merchandizing of the rhymes of violence by profit hungry media companies. As KRS-1 and others tell it, the media companies promote the most outrageous stereotypes of violent, vicious Black youth while ignoring the rappers who represent the positive and political side of ghetto life. (Hip Hop Gangs) Hand in hand with the commercialisation of Hip Hop came far more negative and misogynistic attitudes to women (or bitches as they are widely referred to within Hip Hop). A video youtube3 discusses the use of women in these Hip Hop music videos. One interviewer expresses that women have become adornments, walking objects, portrayed as walking bling. The numbers of girls in videos has increased over the years, going from maybe four or five to forty even fifty. These women are not dressed in a way that can argue this idea, as they are made to wear as little as possible, which most likely turns out to be very revealing underwear or swimwear. Surely the way these videos portray and use women, with the derogatory terms used to describe them questions womanhood today? I recognise that gender is a very key element to the Hip Hop culture in terms of it being a very much male-dominated world, females struggle to match the success levels as the men, and the degrading attitude women are faced with, however I believe to have looked into and covered that would have been a whole essay in itself. I just wish to mention that since Hip Hop has entered the commercial world it has developed into a male dominated genre which portrays women in a disrespectful, objectified and careless way. In its original day, there was never such a strong disregard for women in Hip Hop, and it can only be noticed that it began to have this misogyny opinion when the Hip Hop artist were working with the big music companies. 6. Conclusions Hip Hop came out of a life people were forced to live in of poor healthcare, no money and no hope. Once they realised they could use the media and publicity in their favour to achieve longed for wealth and a chance for more in their lives, they used it so much, they exploited it. African Americans became corrupted by letting their aim and their search for money become their integrity in life. I cannot help but say be careful what you wish for, because you just might get it. As Hip Hop grew and the money in Hip Hop became bigger, more people wanted a piece of the action: managers, promoters, publicists, stylists and most importantly, producers and record companies. Hip Hop (very much like Punk music) was originally an art form that had at its core its rawness and openness you needed no musical training to rap, no instruments to beatbox and no canvass to write graffiti. But now Hip Hop has succumbed to the celebrity culture, and without a major record label, who will want to package and market you, there is little chance of getting your music heard. In the search for record sales, Hip Hop also seemed to lose its integrity and political purpose. Hip Hop, in its early days, did not glorify and encourage violence, drugs and misogyny, it expressed the anger, frustration and suffering young black men were experiencing because of the poor social conditions and lack of opportunities available to them. Today, Hip Hop lyrics and music videos seem to offer a constant diet of violence, drugs and misogyny so much so that it almost becomes bland. How sexist can you be? How many times can you swear in your record? How violent can you (pretend to) be? As Hip Hop artists competed with each other to write more and more extreme lyrics, it quickly became apparent that there was nowhere else to go Hip Hop seems to have reached a stage where everything has already been done. Like other mainstream artists, many rappers sold out and kept their mind on their money and their money on their mind. (Hip Hop Gangs) Today, many of Hip Hops most successful artists are pretenders well educated people, from privileged backgrounds some of whom studied performing arts before becoming Hip Hoppers. Kanye West and Young Jeezy are often mentioned in this way. It seems to me that Hip Hop sold out. It reached a compromise with big business in which both sides used one another to get what they wanted. The record labels would use Hip Hop to generate vast sums of money for themselves, and a few Hip Hop youths would get what they had always wanted: money, recognition for their music and a respect from others. In this essay I hope I have shown that in its early days Hip Hop had an integrity and truth rooted in the experiences of black ghetto youths in North American cities. It had an openness and accessibility any one could participate, anyone could be creative. I also hope I have shown how as Hip Hop grew it very quickly became consumed by the needs of the market and original, creative output was replaced with commercial product. I believe that as a commercial enterprise Hip Hop is still very much alive, in fact it might be said to be bigger than ever, and the gangsta rap culture identity still lives on, not just within music but in fashion, language, film and television. However as an art form I believe it is dead. Hip Hop was an art form that existed out of curiosity, play and freedom. Today through the corporate process every little element has to be questioned and often changed to make the genre be put forward in the most marketable way. The creative control has been lost by being someones money making product. In the music world it is very hard to not be a commercial product, and Hip Hop like many other genres has fallen into that existence. I believe Hip Hop began to die when the real Hip Hoppers dont own Hip Hop anymore. Money took control. The music companies did not have the same interest in Hip Hop as the originators did, their interest was making money, not keeping Hip Hop alive in its purest form. People who did not know anything about real Hip Hop were suddenly having say as to how it would sound. A realisation of this I believe has c

Analytical Test Methods in Downstream Processing

Analytical Test Methods in Downstream Processing Andrea Waldvogel Validation of Analytical Test Methods in Downstream Processing Introduction Quality, safety and efficacy are the main principles of quality assurance of biopharmaceutical drug products. Quality must be designed into the product or process since it cannot be tested into it. Therefore, a quality system must comprise of validation, change control, training, quality control and vendor assurance amongst others.1-3 An effective validation does not only provide a high degree of confidence that the finished drug product consistently and reliably meets all quality requirements but also leads to economic benefits by reducing the cost associated with process monitoring, sampling and testing.4 Biopharmaceutical companies must perform facility, utility and equipment validation/qualification, process validation, computer and computer systems validation, cleaning validation and analytical method validation.5 This project report will focus on analytical method validation, also referred to as analytical procedure validation. Analytical methods are developed to measure characteristics such as molecular identity, purity, potency, and safety of raw materials, in-process samples and final drug products and to monitor the manufacturing process. The number of tests should be adequate to show manufacturing consistency and the impact of changes on the quality of the drug product. All methods must be demonstrated to be fit for their intended purpose before they are employed.5,6 Analytical method validation means establishing documented evidence that provides high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.7 This report begins by providing an overview over some of the regulations and guidelines related to analytical method validation. The second section introduces the modern lifecycle approach to method validation and section three gives an insight into analytical method validation in biopharmaceutical downstream processing. The final section concludes the report with a summary of the main points discussed. There are many different regulations, guidelines and pharmacopeial monographs concerned with analytical method validation. As it would go beyond the scope of this document to write about all of them, the report focuses on some to give an overview. 1.1 Regulations Validation is based on, but not prescribed by regulatory requirement. It is best viewed as an essential and integral part of Good Manufacturing Practice (GMP) for the assurance of quality. Compliance with validation requirements is necessary for obtaining approval for clinical trials and to market new products.4 In the U.S. for example, 21 CFR Part 211.165(e) states8: The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with  § 211.194(a)(2). 21 CFR Part 211.194(a) (2)8: A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (à ¢Ã¢â€š ¬Ã‚ ¦). The suitability of all testing methods used shall be verified under actual conditions of use. The requirement of validation is also implied in 211.100(a)8: There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 1.2 Guidelines The first guidance documents on analytical method validation were published in the 1990s. In the course of time, a lot of revision activity has taken place allowing the incorporation of new approaches to science. The harmonised ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology guideline, issued in 2005, is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures and has tended to take on the role of a regulatory expectation. In the United States, it has been used as a guidance along with the related compendial documents USP Analytical Procedure Validation, Analytical Procedure Verification, and Analytical Procedure Transfer. However, those documents do not provide support for the users to accurately understand and control sources of variability.6,9 In 2013, a Stimuli to the Revision Process paper on Lifecycle Management of Analytical Procedures published by the USP Validation and Verification Expert Panel proposed a Quality by Design (QbD) approach to method development, validation, and performance verification of an analytical method via a lifecycle concept. They suggested that the traditional approaches outlined in the U.S. Pharmacopeial monographs , , and should be revised and assembled into a single new general information chapter Lifecycle Management of Analytical Procedures and a new general chapter specifying the basic requirements. This would, for the first time, formally link method development and method validation within pharmacopeia.6,10 In 2016, a general chapter prospectus on The Analytical Procedure Lifecycle was posted on the U.S. Pharmacopeial Notices and a draft of a new USP General Chapter Statistical Tools for Procedure Validation was published in the U.S. Pharmacopeial Forum (U.S. Pharmacopeial Convention).11,12 In August 2017, a new general USP Chapter Validation of Compendial Methods will become official. This is an effort to better align the validation concept with the revised FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics issued in 2015. However, instead of including a section on Lifecycle Management of Analytical Procedures only a reference has been added. Depending on the development of the chapters and , USP may be revised again.13 Growing awareness that the implementation of an analytical method with adequate quality steps designed into the procedure during the development phase led to the development of a lifecycle approach for analytical procedure validation.10 2.1 Stages of the Modern Lifecycle Approach The modern lifecycle approach is based on the Quality by Design (QbD) approach outlined in ICH Q8(R2) guideline and defines activities and deliverables for every stage of method validation. The following diagram provides an overview. Figure 1: QbD Approach for Analytical Methods 2.1.1 Stage 1: Procedure Design, Development, and Understanding To be able to design quality into a method to ensure that the method is reliable and meets the analytical target profile (ATP) defined at the beginning of this stage, an understanding of how the procedure works is key. Risk assessment should be undertaken to identify variables that could have an influence on the method. The knowledge of variables and their impact is not only important for the development of a control strategy but also for the determination of a design space. The design space will reduce the amount of revalidation work considerably when the method is used operationally. Key elements of this stage are shown in Figure 1 no. 1-3.10 Proper method development including the evaluation of robustness is essential for an effective analytical procedure.10 Robustness is a measure of the methods capacity to remain unaffected by small variations in method parameters and provides an indication of its reliability during normal usage.9 At this stage, system suitability parameters are established which help to ensure that the analytical method remains valid whenever used.9 Without developing a robust method and an understanding of how a change of key parameters will impact its performance, the actual method validation step will be difficult.10 2.1.2 Stage 2: Procedure Performance Qualification The lifecycle approach uses the term procedure performance qualification instead of method validation. Procedure performance qualification is the verification of the performance of the analytical procedure (either a new one or a revised procedure) against the requirements of the ATP.10 If the procedure development has been done correctly, this step should simply be a confirmation that it is fit for the intended purpose. In cases where further controls need to be added to ensure reliable results the analytical control strategy, developed during stage 1, will need an update.10 Method validation work should be performed by a user laboratory under the same conditions as it will be used to comply with existing GMP regulations.10 2.1.3 Stage 3: Implementation and Continued Procedure Performance Verification This stage involves checking how the procedure works during operational use and that it remains in a state of control.10 For this purpose, inputs on reliability and performance of the method gathered from operators and customer complaints will be evaluated. Performance indicators such as system suitability, quality control samples and out-of-specification (OOS) results are tracked and trended.10 The method should be continually improved through corrective and preventive action to reduce the number of out-of-specification (OOS) results. Any change to improve the overall performance needs to be assessed using change control procedures. As shown in Figure 3, the nature of the change specifies what actions have to be taken.6,10,14 Figure 2: Change Types and appropriate Actions 2.2 Traditional (Current) Approach vs Lifecycle Approach In their Stimuli to Revision paper, the USP Expert Panel recommends the adoption of a lifecycle approach for the management of analytical procedures. In their conclusion, they outline the advantages of a lifecycle approach by comparing it to the traditional (current) approach to analytical procedure validation (Figure 1).6 Downstream processing in biopharmaceutical manufacturing involves many steps from recovery over purification to fill finish. Next to in-process monitoring of process parameters such as pH and temperature, analytical testing for the determination of quantity, identity, strength, potency, purity (product- and process related impurities), bioburden and endotoxin has to be performed on raw materials, intermediates, drug substances and finished drug products. Some of the analytical methods in downstream processing are HPLC, gel electrophoresis, PCR, ELISA, Bradford, hemagglutination (HA) and plaque assay. All critical steps in a process have to be validated and less critical steps have to be under control. The criticality of an analytical method is determined by risk assessment. There are various ways to perform method validation. The manufacturer is responsible for choosing the suitable validation procedure and justifying it.1,7,9 3.1 Types of Analytical Procedures The four most common types of analytical procedures are identification tests, qualitative and quantitative tests for impurities and assay. Assay involves the quantitative measurement of the major component(s) in the drug substance and drug product.9 3.2 Team Selection The validation project manager is responsible for the selection of a Cross-Functional-Team (CFT) from various related departments and functional areas. He or she is also in charge of assigning responsibilities and assuring that all personnel involved are trained properly.7 3.3 Analytical Method Validation Protocol The first step in method validation is the preparation of a protocol that defines the work to be done to demonstrate that the method is fit for its intended use.7,10 The analytical method validation protocol should contain the following sections: Purpose Short description of what is to be accomplished Scope of the project specifying the test methods and products Overview General description of the test method Summary of the characterisation studies Identification of method type and validation approach Test method applications and validation protocol Intended use of each test method application Analytical performance characteristics for each test method application Resources End user laboratory where the method validation is to be performed Equipment and materials to be used in the method validation Special instructions on handling, stability, and storage for each material Appendices References, signature, and a review worksheet for all personnel Specific tasks for all personnel and documentation of their training Listings of all equipment and software necessary to perform the method validation Document and materials worksheets used in method validation Test method procedures (SOPs) Before the method validation can begin the protocol must be agreed upon by the CFT and approved.7 3.4 Performance Characteristics Tests Performance characteristics and their acceptance criteria are defined during the characterisation studies at the development stage of the analytical method. Depending on the method and its intended use, some performance characteristics tests may be omitted, the number of replicates may be increased or reduced, or acceptance criteria may be adapted. All decisions have to be based on scientifically sound judgment. It is important that well characterised reference materials, with documented purity, are used for testing performance characteristics.7,9 The following table outlines the performance characteristics and their meaning, test procedures, how data should be reported and acceptance criteria according to ICH Q2(R1) and FDA Guidance for Industry on Analytical Procedures and Method Validation. Accuracy Closeness of test results to the true value For drug substances, accuracy measurements are obtained by comparing test results to the analysis of a standard reference material or to a second, well-characterized method. For drug products, accuracy is evaluated by analysing synthetic mixtures (containing all excipient materials in the correct proportions) spiked with known quantities of analyte. Guidelines recommend that data be collected from a minimum of nine determinations over at least three concentration levels covering the specified range. The data should be reported as the percent recovery of the known, added amount, or as the difference between the mean and true value with confidence intervals (such as  ±1 SD). Acceptability criteria are defined by end users but rarely fall outside 97-103% of the nominal value. Statistical analysis can be applied using a one sample t-test. Precision Degree of agreement among test results when the method is applied repeatedly to multiple samplings of a homogeneous sample Precision is commonly described in terms of repeatability, intermediate precision, and reproducibility: Repeatability is investigated by analysing a minimum of nine determinations using the same equipment and sample, covering the specified range of the procedure, or a minimum of six determinations at 100% of the test concentration and reported as percent relative standard deviation (RSD). Intermediate precision refers to the agreement among the results from a single laboratory, despite potential variations in sample preparation, analysts, or equipment. Reproducibility refers to the agreement among the results from different laboratories. Results are reported as % RSD, and the percent difference in the mean values between the analysts must be within specifications. Less than 2% RSD is often recommended, but less than 5% RSD can be acceptable for minor components. Specifity Ability to measure accurately and specifically the analyte of interest in the presence of other components In drug assays, specificity takes into account the degree of interference from other active ingredients, excipients, impurities, degradation products, or matrices. In chromatography, it ensures that a chromatographic peak corresponds to a single component. Specificity can be demonstrated by the resolution between peaks of interest. Limit of detection (LOD) Lowest concentration of an analyte in a sample that can be detected In a chromatography laboratory, the most common way to determine both the LOD and the LOQ is using signal-to-noise ratios (S/N), commonly 3:1 for LOD and 10:1 for LOQ. An appropriate number of samples must be analyzed to fully validate the method performance at the limit. Limit of quantitation (LOQ) Lowest concentration of an analyte in a sample that can be quantified with acceptable precision and accuracy under the stated operational conditions of the method Linearity Ability of a method to provide results that are directly proportional to analyte concentration within a given range Guidelines specify that a minimum of five concentration levels be used to determine the range and linearity, along with certain minimum specified ranges depending on the type of method. The range is normally expressed in the same units as the test results obtained by the method (for example, nanograms per millilitre). Data to be reported generally include the equation for the calibration curve line, the coefficient of determination (r 2), residuals, and the curve itself. Range Interval between the upper and lower concentrations of an analyte that have been demonstrated to be determined with acceptable precision, accuracy, and linearity using the method Robustness Measure of a methods capacity to obtain comparable and acceptable results when perturbed by small but deliberate variations in procedural parameters It provides an indication of the methods suitability and reliability during normal use. During a robustness study, method parameters (such as eluent composition, gradient, and detector settings) are intentionally varied to study the effects on analytical results. Common chromatography parameters used to measure and document robustness include critical peak pair resolution (R s), plate number (N) or peak width in gradient elution, retention time (t R), tailing factor (T F), peak area (and height) and concentration. Robustness studies are expected to be done during method development. Table 7 gives an overview of the performance characteristic tests that have to be performed on different types of analytical procedures.9 Figure 6: Performance Characteristic tests performed on different Types of Analytical Procedures The performance characteristics are evaluated by comparing the results to the specifications defined at the development stage. An analytical method is considered to be validated when it meets the specifications defined at the development stage. Once an analytical method has been made a formal part of the manufacturing process, it is extremely difficult to remove it. In the event of changes in the drug substance, the composition of the finished product and in the analytical procedure, revalidation may be necessary.5,7,9 3.5 Validation Documentation Every validation step needs to be documented to be able to provide written evidence to the regulatory authorities that a specific method is fit for its purpose. Documentation associated with method validation are validation protocols, standard operating procedures (SOPs), specifications and validation reports. Downstream processing in biopharmaceutical manufacturing involves many analytical methods which help to ensure quality, safety and efficacy of the final drug product. Development, validation and control of a robust analytical method is a lengthy and difficult task. However, without written evidence that an analytical method is fit for its intended use the company will not obtain a marketing authorisation. Over time, many guidelines and pharmacopeial monographs have been issued and a lot of revision activity has happened especially following the Stimuli to Revision paper published in 2013. Even though, no comprehensive guideline or monograph incorporating the modern lifecycle approach has been issued yet. Although proper development of robust and effective analytical methods is more time-consuming and expensive, it has many advantages. It leads to more efficient validation, variability is reduced and controlled and analytical method-related out-of-specification results and failure investigation are minimised. Additionally, changing method parameters within the design space facilitates continual improvement as it does not require regulatory re-approval. Validation is a team effort. Members of the CFT need to be properly trained. Their first and most demanding task is the preparation of a protocol which defines the scope of the validation project and provides all details necessary for a successful validation. It also defines, depending on the type of the analytical procedure, which performance characteristics need to be tested. The use of well characterised reference materials with known purity is important. Analytical method validation is considered to be complete when all acceptance criteria are met and a validation report has been written.       Bibliography References 1 Choudhary, A. (2009). Validation in Pharmaceutical Manufacturing. Pharmaceutical Guideline. [Accessed on 1 March 2017]. Available on Internet: http://www.pharmaguideline.com/2010/12/validation.html 2 International Conference on Harmonization (2009). Harmonised Tripartite Guideline: ICH Q8(R2) Pharmaceutical Development. [Accessed on 1 March 2017]. Available on Internet: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf 3 Stockbridge, P. (2008). Biopharmaceutical Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Devices. BioProcess International. [Accessed on 7 March 2017]. Available on Internet: http://www.bioprocessintl.com/2008/biopharmaceutical-quality-assurance-184041/ 4 Nandhakumar, L.; Dharmamoorthy, G.; Rameshkumar, S.; Chandrasekaran, S. (2011). An Overview of Pharmaceutical Validation: Quality Assurance View Point. IJRPC, 1(4). [Accessed on 1 March 2017]. Available on Internet: http://www.caidat.org/m4atomp3/2561456335400862.pdf 5 Lutz, H. (2005). Introduction to Validation of Biopharmaceuticals. BioPharm International. [Accessed on 1 March 2017]. Available on Internet: http://www.biopharminternational.com/introduction-validation-biopharmaceuticals 6 USP Validation and Verification Expert Panel (2013). Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Stimuli to the Revision Process Article. [Accessed on 1 March 2017]. Available on Internet: https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/lifecycle_pdf.pdf 7 Shabir, G. A. (2004). Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry. IVT Network: Analytical Method Validation, pp. 4-14. [Accessed on 2 March 2017]. Available on Internet: http://www.ivtnetwork.com/sites/default/files/Analytical%20Method%20Validation.pdf 8 U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Parts 211.165(e), 211.194(a) and 211.100(a). [Accessed on 2 March 2017]. Available on Internet: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=211 9 International Conference on Harmonization (2005). Harmonised Tripartite Guideline: ICH Q2(R1) Validation of Analytical Procedures, Text and Methodology. [Accessed on 1 March 2017]. Available on Internet: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html 10 McDowall, R. D. (2014). GLP and GMP Approaches to Method Validation Going the same Way?. Spectroscopy, 29(4). [Accessed on 1 March 2017]. Available on Internet: http://www.spectroscopyonline.com/glp-and-gmp-approaches-method-validation-going-same-way 11 U.S. Pharmacopeial Convention (2016). General Chapter Prospectus: The Analytical Procedure Lifecycle. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/notices/1220-analytical-procedure-lifecycle 12 U.S. Pharmacopeial Convention (2014). New USP requirements for Analytical Method Validation. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/pharmacopeial-forum 13 ECA Academy (2017). Revised USP Chapter Validation of Compendial Methods approved. [Accessed on 2 March 2017]. Available on Internet: http://www.gmp-compliance.org/gmp-news/revised-usp-chapter-1225-validation-of-compendial-methods-approved 14 Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/flyers/Public/Recent_regulatory_updates_and_trends_in_analytical_method_validation.pdf Illustrations Figure 1: Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/fl