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GMP Publications - Code of Federal Regulation Handbooks by the FDA

Drug GMPs

GMP International Master Reference Guide
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
21 CFR 210/211 - Drug GMPs
21 CFR 11, 210/211 - Electronic Records with Drug GMPs
FDA DEA GMP Master Reference Guide
503B Compounding Master Guide
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
21 CFR 11, 210/211 with Keyword Index
21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs
21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
21 CFR 11, 58, 210/211, 820, ICH E6(R2) - GMP 2 Combination Handbook
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 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 11, 820 QSR and 830 UDI
21 CFR 4 - Regulation of Combination Products
Title 21 CFR Parts 1 - End Nine Volume Set
EU cGMPs for ATMP with EU GMP Chapters 1-9
21 CFR Part 207 Registration
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
ICH Q2(R2) and ICH Q14 Analytical Validation
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
GMP Manufacturing Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
GMP Boot Camp Training Certificate and GMP Handbook
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match Interphex 2024 Sterile GMP End of Year Special New Books GMP GCP-DRUG Featured Publication Featured Publication
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