COMMENTARY Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System Richard L. Friedman Food & Drug Administration‚ Center for Drug Evaluation & Research‚ Division of Manufacturing & Product Quality ABSTRACT: This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The
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Music may be defined romantically as `the food of love ’ (Shakespeare) or more prosaically as `sound with particular characteristics ’ (Wikipedia)‚ but it is undeniably a `vibrant artform ’ (Arts Council England) and one which touches more people‚ in more ways‚ than any other art form. In commercial terms‚ music certainly generates a higher market value than the other arts‚ although a comprehensive market size for music in all its manifestations is impossible to calculate. Key Note has put a value
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Pharmaceutical Society of Great Britain v Boots [1953] 1 QB 401 Court of Appeal Boots introduced the then new self service system into their shops whereby customers would pick up goods from the shelf put them in their basket and then take them to the cash till to pay. The Pharmaceutical Society of Great Britain brought an action to determine the legality of the system with regard to the sale of pharmaceutical products which were required by law to be sold in the presence of a pharmacist. The court
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Characteristics Business/Personal Computer Industry Market size: $321 Billion annual revenues worldwide; 357 million units sold annually worldwide Scope of competitive rivalry: The competition within the PC industry is extremely cut throat due to new technology‚ reliability‚ and customer service. The top companies consist of Dell‚ Hewlett Packard‚ Apple‚ Gateway‚ and Sony. Market growth rate: 14% annually Stage in life cycle: Mature Number of companies in industry: There are 5 major PC companies
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Pharmaceutical Master Validation Plan The Ultimate Guide to FDA‚ GMP‚ and GLP Compliance SL3305_ FM_fm Page ii Thursday‚ November 8‚ 2001 3:07 PM Pharmaceutical Master Validation Plan The Ultimate Guide to FDA‚ GMP‚ and GLP Compliance Syed Imtiaz Haider‚ Ph.D. ST. LUCIE PRES S A CRC Press Company Boca Raton London New York Washington‚ D.C. SL3305_ FM_fm Page iv Thursday‚ November 8‚ 2001 3:07 PM Every effort has been made to ensure that the contents of this generic validation master plan
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& Services Fast-track Pharmaceutical Facilities a report by NNE Being the first to market has been the key to success in almost every manufacturing industry. This increasingly applies to the pharmaceutical and biotech industries. Pharmaceutical companies want to be able to get their discoveries into production as soon as the last regulatory hurdle in the clinical trials has been passed. “The biotech industry is going to become similar to the electronics industry”‚ Hans Ole Voigt‚ General
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RBUS2900 Case Study Part 1 Question 1: Provide an interpretation of the output to describe the following variables: Satisfaction Level (X7)‚ Safety Level (X8)‚ Safety Rating (X9)‚ and Type of Industry (X10) Answer 1: Satisfaction Level (X7) The average satisfaction rating by the 160 customers who have had past purchases from ManuFactu-R-US was 5. There was small standard deviation of only 1‚ with the majority of customer ratings ranging between 4 and 6. The maximum rating given was 7 and the
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ryANALYSIS OF PAINTS INDUSTRY IN INDIA Introduction: The paints industry made a beginning in India in 1902 when Shalimar Paints set up its operations in Kolkata (Calcutta). Today the size of the paints market in India is estimated at Rs 180 bn. Market Structure & Product category: The Indian Paint industry can be divided as: * The organized sector comprising of large and medium size units * The unorganized or the small scale sector. The contribution of the organised and unorganised
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CORPORATE SOCIAL PRACTICES IN BANGLADESH: A STUDY ON PHARMACEUTICAL SECTORS IN BANGLADESH. Report On CORPORATE SOCIAL PRACTICES IN BANGLADESH: A STUDY ON PHARMACEUTICAL SECTORS IN BANGLADESH. Course Code: BUS-498 Submitted to: Md. Jahirul Islam Lecturer‚ ASAUB Submitted by: Farhana Bhuiyan ID# 073-12-0020 BBA 3rd Batch‚ ASAUB [pic] ASA UNIVERSITY BANGLADESH December‚ 2011 Declaration of originality
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CIM 2010 Cultural (Industry) Management Analysis of the Diamond Industry Becky Gong Culture‚ Creativity and Management 1. Why Interested? A diamond is forever. No one will be unfamiliar with this classical advertising verbal. Diamonds have symbolized love and eternity for centuries‚ which can still be constantly found in some of the world’s oldest pieces of jewelry. They were surrounding by myths and legends and once regarded as the “Tears of the
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