GMP Publications - Code of Federal Regulation Handbooks by the FDA

Misc Handbooks

21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
21 CFR 110 - Food GMPs-SPANISH
21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
21 CFR 210/211 - Drug GMPs-SPANISH
21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH
21 CFR 820 - Quality System Regulations-SPANISH
Canadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011
Electronic Systems Master Handbook 1
EU and US GMPs with Q7 API
EU and US GMPs with Annex 1
EU and US GMPs with Annexes 11 and 15
EU and US GMPs with ICH Q7, Q8, Q9, Q10
EU GMPs Chapter 1 - 9
EU GMPs with Annex 11, 15, 16 and ICH Q7
EU GMPs with Annex 11, 15, 16, 18, 19
EU GMPs with Annex 13 Investigational medicinal Products
EU GMPs with Annex 14 Human Blood or Plasma Products
EU GMPs with Annex 15 Qualification and Validation
EU GMPs with Annex 16 Qualified Person and Batch Release
EU GMPs with Annex 19 Reference and Retention Samples
EU GMPs with Annex 2 Biological
EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
EU GMPs with ICH Q7
ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q7, Q8, Q9 and Q10 Combination
ICH Q7, Q8, Q9 and Q10 with FAQ
Japanese GMP for Drugs and Quasi-drugs - 2005
Medical Device Clinical with EU Directive
US and Canadian GMPs with ICH Q7, Q8, Q9, Q10
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA
Audit Fee US
example: 211, (ISBN), ...xxx-60-9,, Drug, GMP, Etc.
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