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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Drug GMPs

GMP International Master Reference Guide
21 CFR 210/211 - Drug GMPs
FDA DEA GMP Master Reference Guide
503B Compounding Master Guide
21 CFR 111 - Dietary Supplement handbook
21 CFR 200, 201 - General Drug & Drug Labeling Combination
21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
21 CFR 210/211 - Drug GMPs-SPANISH
21 CFR 210/211 with Drug Preambles
21 CFR 210/211 with Keyword Index
Canadian GMP Guidelines GUI-0001 July 1, 2020
US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
EU GMPs Chapter 1 - 9
EU GMPs with ICH Q7, Q8(R2), Q9(R1) and Q10
GMP - PAT Handbook
US, EU and Japanese GMPs
Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA
ICH Q7 with Q7 Auditors Check List
ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
21 CFR 4 - Regulation of Combination Products
Title 21 CFR Parts 1 - End Nine Volume Set
GLP Manufacturing Handbook - 4.5x7.5
EU cGMPs for ATMP with EU GMP Chapters 1-9
21 CFR Part 207 Registration
ICH Q2(R2) and ICH Q14 Analytical Validation
ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
Standard Sterile Product Manufacturing Handbook
EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
GMP Manufacturing Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
GMP Training, Certificate, GMP Handbook & e-Workbook
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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