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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Miscellaneous Title 21 Parts

21 CFR 13 - Public Hearing
21 CFR 200 - General Drug
21 CFR 200, 201 - General Drug & Drug Labeling Combination
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Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10
ICH Q7 with Q7 Auditors Check List
VICH GL9 Animal GCP
Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA
21 CFR 11, 110, 117, 120 - Food GMPs
21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH
21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
21 CFR 320 - Bioavailability and Bioequivalence Requirements
21 CFR 112 - Produce for Human Consumption - SPANISH
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
In Vitro Diagnostics 2017/746 Medical Devices
ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
GMP Medical Device Master Reference Guide
21 CFR Part 112 Produce and 117 Food GMPs
Standard Sterile Product Manufacturing Handbook
FDA DEA GMP Master Reference Guide
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
21 CFR 4 - Regulation of Combination Products
503B Compounding Master Guide
ICH Q2(R2) and ICH Q14 Analytical Validation
In Vitro Diagnostics Master Handbook
GMP International Master Reference Guide
GMP Manufacturing Handbook
GMP Boot Camp Training Certificate and GMP Handbook
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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