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GMP Consulting

Руководящие документы по надлежащей производственной практике FDA


What Is GMP



Title Тема
Стерильное производство:
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
Part 11, Electronic Records; Electronic Signatures — Scope and Application Posted 9/3/2003 Часть 11, Электронные записи; Электронная подпись.
Guidance for Industry Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information
Guidance for Industry
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
Не стерильное производство:
Guidance for Industry SUPAC-SS: Nonsterile Semisolid Dosage Forms Руководство по производству нестерильных лекарственных препаратов


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