Fifth Edition
by Michael Anisfield

This book contains the English language texts of all GMPs (regulations, guidelines, codes, and practices) implemented by national and international regulatory authorities that govern the manufacture and testing of biotechnology-derived products, active pharmaceutical ingredients, and pharmaceuticals.

Prepared with the cooperation of health authorities worldwide, this resource contains the GMPs in effect in 114 countries, plus GMP regulations of the World Health Organization (including the 1996 WHO GMPs), the European Union, the Association of South East Asian Nations, and the Pharmaceutical Inspection Convention.

Contents Include

• Summary of worldwide GMP requirements
• Summary of world pharmacopoeias
• GMPs in effect in 114 countries
• GMPs for pharmaceuticals, sterile and nonsterile
• GMPs for bulk pharmaceutical chemicals, sterile and nonsterile
• GMPs for biotechnology products
• GMPs for in vitro diagnostic products
• Addresses for regulatory agencies worldwide

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