Misc Handbooks
| 21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH |
| 21 CFR 210/211 - Drug GMPs-SPANISH |
| 21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH |
| 21 CFR 820 - Quality System Regulations-SPANISH |
| Canadian GMP Guidelines GUI-0001 July 1, 2020 |
| Electronic Systems Master Handbook 1 |
| EU and US GMPs with Q7 API |
| EU and US GMPs with Annex 1 |
| EU and US GMPs with Annexes 11 and 15 |
| US and EU GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 |
| EU GMPs Chapter 1 - 9 |
| EU GMPs with Annex 11, 15, 16 and ICH Q7 |
| EU GMPs with Annex 11, 15, 16, 18, 19 |
| EU GMPs with Annex 13 Investigational medicinal Products |
| EU GMPs with Annex 14 Human Blood or Plasma Products |
| EU GMPs with Annex 15 Qualification and Validation |
| EU GMPs with Annex 16 Qualified Person and Batch Release |
| EU GMPs with Annex 19 Reference and Retention Samples |
| EU GMPs with Annex 2 Biological |
| EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products |
| EU GMPs with Annex 8 Sampling of Starting and Packaging Materials |
| EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments |
| EU GMPs with ICH Q7 |
| ICH Q7 with Q7 Auditors Check List |
| ICH Q7, Q8(R2), Q9(R1) and Q10 Combination |
| ICH Q7, Q8(R2), Q9(R1) and Q10 with FAQ |
| Japanese GMP for Drugs and Quasi-drugs - 2005 |
| Medical Device Clinical with EU Directive |
| US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 |
| US, EU and Canadian Medical Device Combination |
| US, EU and Japanese GMPs |
| Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA |
| 21 CFR Part 117 - Food GMPs |
| VICH GL9 Animal GCP |
| 21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
| Drug & Device GMP Desk Reference Set |
| 21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH |
| 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| 21 CFR 320 - Bioavailability and Bioequivalence Requirements |
| 21 CFR 112 - Produce for Human Consumption - SPANISH |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 |
| Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
| EU Medical Device Regulation 2017-745 |
| 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 |
| In Vitro Diagnostics 2017/746 Medical Devices |
| ICH Q7, Q8(R2), Q9(R1), Q10 and Q11 |
| GMP Medical Device Master Reference Guide |
| 21 CFR Part 112 Produce and 117 Food GMPs |
| Standard Sterile Product Manufacturing Handbook |
| Dietary Supplement Master Handbook |
| EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products |
| ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination |
| FDA DEA GMP Master Reference Guide |
| 21 CFR 4 - Regulation of Combination Products |
| 503B Compounding Master Guide |
| Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs |
| ICH Q2(R2) and ICH Q14 Analytical Validation |
| In Vitro Diagnostics Master Handbook |
| Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14 |
| GMP International Master Reference Guide |
| GMP Manufacturing Handbook |
| GMP Boot Camp Training Certificate and GMP Handbook |
| Title 21 CFR Parts 1 - End Nine Volume Set |
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