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Руководящие документы по надлежащей производственной практике FDA
Руковадящие документы:
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| Стерильное производство: | ||||
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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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| Не стерильное производство: | ||||
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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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