GMP Combination Handbooks
| Canadian GMP Guidelines GUI-0001 July 1, 2020 |
| Drug & Device GMP Desk Reference Set |
| 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| Medical Device Quality Systems Manual with 820 and QSR Audit Checklist |
| US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 |
| Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
| Canadian - SOR98-282 Medical Devices Regulations |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19 |
| 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 |
| Electronic Systems Master Handbook 1 |
| US, EU and Japanese GMPs |
| GMP - PAT Handbook |
| ICH Q7 with Q7 Auditors Check List |
| GMP Medical Device Master Reference Guide |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 |
| ICH Q7, Q8(R2), Q9(R1), Q10 and Q11 |
| 21 CFR Parts 112 and 117 - ENGLISH/SPANISH |
| 21 CFR Part 112 Produce and 117 Food GMPs |
| ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination |
| Standard Sterile Product Manufacturing Handbook |
| Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA |
| 21 CFR 4 - Regulation of Combination Products |
| 503B Compounding Master Guide |
| FDA DEA GMP Master Reference Guide |
| ICH Q2(R2) and ICH Q14 Analytical Validation |
| In Vitro Diagnostics Master Handbook |
| GMP International Master Reference Guide |
| 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 |
| Title 21 CFR Parts 1 - End Nine Volume Set |
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