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Руководящие документы по надлежащей производственной практике FDA
Руковадящие документы:
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Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice |  |
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Part 11, Electronic Records; Electronic Signatures — Scope and Application Posted 9/3/2003 | Часть 11, Электронные записи; Электронная подпись. | |
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Guidance for Industry Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information | |
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Guidance for Industry Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations |
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Guidance for Industry SUPAC-SS: Nonsterile Semisolid Dosage Forms | Руководство по производству нестерильных лекарственных препаратов | |
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Cosmetic Good Manufacturing Practice Guidelines | |||
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Guidance for Industry
Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation |
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International Biotechnology, Bulk Chemical, and Pharmaceutical GMPs, Fifth Edition 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. Paperback: 716 pages |
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123MB | |
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