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GMP Publications - Code of Federal Regulation Handbooks by the FDA

New Books and Updated Parts - 2024!

21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
Updated 2024 - 21 CFR 50 - Protection of Human Subjects
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook
ICH Q2(R2) and ICH Q14 Analytical Validation
21 CFR Part 121 Mitigation Strategies
21 CFR Part 207 Registration
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
Canadian - SOR98-282 Medical Devices Regulations
Standard Sterile Product Manufacturing Handbook
EU GMPs with Annex 1 Sterile Medicinal Products
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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