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Руководящие документы по надлежащей производственной практике FDA

 

Title Тема
Inspection Guides Руководства для инспекторов
Process Analytical Technology (PAT) Процессно аналитическая технология
   
   

 

 

What Is GMP

Книги

Руковадящие документы:
Title Тема
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Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
21 CFR 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
 
21 CFR PART 600—BIOLOGICAL PRODUCTS: GENERAL      
21 CFR PART 606—CURRENT GOOD MANUFACTURING
PRACTICE FOR
BLOOD AND BLOOD COMPONENTS
     
21 CFR PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
     

21 CFR PART 800—MEDICAL DEVICES GENERAL
     
21 CFR PART 820—QUALITY SYSTEM
REGULATION
     
Не стерильное производство:
Guidance for Industry SUPAC-SS: Nonsterile Semisolid Dosage Forms Руководство по производству нестерильных лекарственных препаратов
Cosmetic Good Manufacturing Practice Guidelines      
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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Название
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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
123MB

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