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 |
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 |
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