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oms-catalogue 15/07/03 11:33 Page 10 QUALITY ASSURANCE AND SAFETY Quality Assurance of Pharmaceuticals A Compendium of Guidelines and Related Materials Volume 1 Quality Assurance of Pharmaceuticals A Compendium of Guidelines and Related Materials Volume 2: Good Manufacturing Practices and Inspection Quality Control Methods for Medicinal Plant Materials 10 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. Draws together twelve WHO guidelines related to good manufacturing practives (GMP) and to the inspection of pharmaceutical manufacturers and distribution channels. Most of these guidelines have appeared as annexes in various reports of the WHO Expert Commitee on Specifications for Pharmaceutical Preparations. By making these available in a single reference work, the book facilitates access to the complete body of WHO guidelines and recommendations aimed at ensuring the pharmaceutical products are manufactured in compliance with internationally accepted standards for quality and safety. A collection of recommended test procedures for assessing the identity, purity, and content of medicinal plant materials. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures – whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities – should also prove useful to the pharmaceutical industry and pharmacists working with these materials. 1997, vi + 238 pages [E, F, R] ISBN 92 4 154504 6 Swiss francs 50.–/US $45.00 In developing countries: Sw.fr. 35.– Order no. 1150452 1999, v + 198 pages [E, F*, R] ISBN 92 4 154526 7 Swiss francs 62.–/US $55.80 In developing countries: Sw.fr. 43.40 Order no. 1152452 1998, viii + 115 pages [E] ISBN 92 4 154510 0 Swiss francs 35.–/US $31.50 In developing countries: Sw.fr. 24.50 Order no. 1150451
oms-catalogue 15/07/03 11:33 Page 11 WHO Expert Committee on Specifications for Pharmaceutical Preparations Thirty-seventh Report WHO Expert Committee on Specifications for Pharmaceutical Preparations Thirty-sixth Report This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. This committee reviews and adopts guidelines that have been prepared reflecting consensus obtained during a large international consultative process. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by agencies of the United Nations. Technical Report Series, No. 908 2002 , viii + 136 pages [E] ISBN 92 4 120908 9 Swiss francs 25.–/US $22.50 In developing countries: Sw.fr. 17.50 Order no.1110908 Sets out a series of twelve international guidelines and other recommendations intended to assist national drug regulatory authorities and manufacturers in the quality assurance of pharmaceutical products. The report also responds to the need to extend previously issued WHO guidelines for good manufacturing practices (GMP) to cover several special circumstances as well as guidance for inspectorates. List of adopted guidelines: Quality Control Laboratory related: • Guideline on "Good Practices for National Pharmaceutical Control Laboratories" (with Model Test Report and List of equipment for pharmaceutical control laboratories appended) • Model Certificate of Analysis • Considerations for requesting analysis of drug samples • List of International Chemical Reference Substances • List of International Infrared Reference Spectra GMP (updates and reviews) • GMP in pharmaceutical production (essential elements) • GMP for sterile pharmaceutical products (updated text) Inspection related: • Guidelines on Pre-approval inspection • WHO quality systems requirements for national GMP inspectorates • Guidance on "comparative products" for equivalence assessment of interchangeable multisource (generic) products • General Aspects of Packaging • Guidelines on the use of INN for Pharmaceutical Substances Technical Report Series, No. 902 2002, 215 pages [E, F*, S] ISBN 92 4 120902 X Swiss francs 42.–/US $37.80 In developing countries: Sw.fr. 29.40 Order no. 1100902 11
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