Draws together twenty-two WHO guidelines relevant to the quality assurance and control of pharmaceutical products. Most of these guidelines have appeared as annexes in various reports of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Others are published here for the first time. By making these available in a single reference work, the book facilitates access to the complete body of WHO guidelines and recommendations issued to assist national drug regulatory and control authorities, particularly ...
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Draws together twenty-two WHO guidelines relevant to the quality assurance and control of pharmaceutical products. Most of these guidelines have appeared as annexes in various reports of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Others are published here for the first time. By making these available in a single reference work, the book facilitates access to the complete body of WHO guidelines and recommendations issued to assist national drug regulatory and control authorities, particularly in developing countries. When viewed together, the collected guidelines also underscore the need for a comprehensive system of quality assurance and illustrate its various technical and administrative components in a logical way. The book has nine chapters organized to reflect the sequence of administrative and technical procedures needed to ensure that drugs meet acceptable standards of quality, safety, and efficacy. Chapter one sets out guiding principles for small national drug regulatory authorities. The second and most extensive chapter, on product assessment and registration, gives guidelines for the assessment of herbal medicines, the stability of drug dosage forms, the stability testing of products containing well established drug substances, and registration requirements to establish the interchangeability of multisource (generic) pharmaceutical products. Other chapters present recommendations for quality assurance in pharmaceutical supply systems, use of the International Pharmacopoeia to control the identity, purity and quality of products, and the development of simplified tests for verifying the identity of pharmaceutical products. A chapter on laboratory services contains proposed models for a first-stage laboratory for drug surveillance, and a medium-size drug control laboratory. The remaining chapters provide guidelines for international trade in pharmaceuticals, recommendations for dealing with the new threat posed by counterfeit products, and advice on training programmes for personnel conducting drug analysis for regulatory purposes.
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Add this copy of Quality Assurance of Pharmaceuticals: a Compendium of to cart. $39.58, good condition, Sold by Anybook rated 5.0 out of 5 stars, ships from Lincoln, UNITED KINGDOM, published 1997 by World Health Organisation.
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Volume 1. This is an ex-library book and may have the usual library/used-book markings inside. This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 650grams, ISBN: 9241545046.
Add this copy of Quality Assurance of Pharmaceuticals: a Compendium of to cart. $41.27, good condition, Sold by Anybook rated 5.0 out of 5 stars, ships from Lincoln, UNITED KINGDOM, published 1997 by World Health Organisation.
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Seller's Description:
Volume 1. This is an ex-library book and may have the usual library/used-book markings inside. This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 650grams, ISBN: 9241545046.
Add this copy of Quality Assurance of Pharmaceuticals: A Compendium of to cart. $42.52, new condition, Sold by Ingram Customer Returns Center rated 5.0 out of 5 stars, ships from NV, USA, published 1997 by World Health Organization.
Add this copy of Quality Assurance of Pharmaceuticals: a Compendium of to cart. $43.32, new condition, Sold by Paperbackshop rated 4.0 out of 5 stars, ships from Bensenville, IL, UNITED STATES, published 1998 by World Health Organization.
Add this copy of Quality Assurance of Pharmaceuticals: A Compendium of to cart. $43.71, new condition, Sold by Ria Christie Books rated 4.0 out of 5 stars, ships from Uxbridge, MIDDLESEX, UNITED KINGDOM, published 1997 by World Health Organization.
Add this copy of Quality Assurance of Pharmaceuticals: a Compendium of to cart. $54.67, poor condition, Sold by Anybook rated 5.0 out of 5 stars, ships from Lincoln, UNITED KINGDOM, published 1997 by World Health Organisation.
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Volume 1. This is an ex-library book and may have the usual library/used-book markings inside. This book has soft covers. Book contains pen, pencil & highlighter markings. In poor condition, suitable as a reading copy. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 650grams, ISBN: 9241545046.
Add this copy of Quality Assurance of Pharmaceuticals: A Compendium of to cart. $58.92, new condition, Sold by Booksplease rated 3.0 out of 5 stars, ships from Southport, MERSEYSIDE, UNITED KINGDOM, published 1997 by World Health Organization.
Add this copy of Quality Assurance of Pharmaceuticals: a Compendium of to cart. $62.40, new condition, Sold by Russell Books rated 4.0 out of 5 stars, ships from Victoria, BC, CANADA, published 1997 by World Health Organization.