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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 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 GUI-0001 July 1, 2020
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
US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), 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 with Q7 Auditors Check List
ICH Q7, Q8(R2), Q9(R1) and Q10 Combination
ICH Q7, Q8(R2), Q9(R1) 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(R2), Q9(R1), Q10
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA
21 CFR Part 117 - Food GMPs
VICH GL9 Animal GCP
21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Drug & Device GMP Desk Reference Set
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 11, 110, 117, 120 - Food GMPs
21 CFR 112 - Produce for Human Consumption - SPANISH
EU cGMPs for ATMP with EU GMP Chapters 1-9
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
EU Medical Device Regulation 2017-745
US FDA, Canadian and European MDR
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
Dietary Supplement Master Handbook
EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products
ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
21 CFR 11, 820 QSR and 830 UDI
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
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
ICH Q2(R2) and ICH Q14 Analytical Validation
In Vitro Diagnostics Master Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
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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