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Combination Product Handbooks

21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024
GMP Medical Device Master Reference Guide
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
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
GMP Manufacturing Handbook
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
Title 21 CFR Parts 1 - End Nine Volume Set
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