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NEW! - ICH Q9 Quality Risk Management - Search ICH Q9 Handbooks
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NEW! August 2023 Updated EU GMP Annex 1 Manufacturer of Sterile Medicinal Products
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- 21 CFR 210/211 - Drug GMPs - The basic GMPs for every Employee!
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- 21 CFR Parts 210/211, Part 11 Electronic Systems and 820 QSR for Device
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- 21 CFR 820 - Quality System Regulations
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- 21 CFR Part 820, Quality Manual with Audit Checklist with ISO 13485 References
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- 21 CFR 112 Produce for Human Consumption also in a combination English / Spanish
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- 21 CFR Part 112 Produce for Human Consumption in both English and Spanish
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- 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
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- 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - GCP Medical Device Combination
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- 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - IND/NDA Good Clinical Practice Handbook
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- GMP International Pharmaceutical Master Reference Guide - Over 900 pages of Guidance and Regulations
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- GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745
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$36.95 |
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- Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements
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- 21 CFR Part 117 - Food GMPs - Hazard Analysis, and Risk-Based Preventive Controls for Human Food
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Other Master Regulations and Guidance Handbooks - Pricing Discounts Available:
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| Our New and Best Sellers - Don't Forget to Try out Mix and Match Parts! Create Your Own Handbooks (minimum Qty applies): |
| 21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs |
| 21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master |
| 21 CFR 4 - cGMP for Combination Products |
| 21 CFR 11 - Electronic Records with Scope & Application |
| 21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist |
| 21 CFR 11 - Electronic Records with Scope & Application and Preambles |
| 21 CFR 11 - with Scope & Application & Computerized Systems used in Clinical Investigations |
| 21 CFR 11, 101, 110, 117, 120, 123 - GMPs for Fish Industry with Food Labeling |
| 21 CFR 11, 110, 111 and 117 - Food and Supplement GMPs |
| 21 CFR 11, 110, 117, 120 - Food GMPs |
| 21 CFR 11, 110, 117, 120, 123 - GMPs for Fish Industry |
| 21 CFR 11, 110, and 117 - Electronic Records with Food GMPs |
| 21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs |
| 21 CFR 11, 203, 205 - PDMA with Electronic Records |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH |
| 21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH |
| 21 CFR 11, 210/211 with Keyword Index |
| 21 CFR 11, 210/211, 606, 820 - Electronic Records with Drug, Blood and Device QSR Industry GMPs |
| 21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug" |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH |
| 21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH |
| 21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook |
| 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook |
| 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook |
| 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
| 21 CFR 11, 58 - Electronic Records with Scope & App. and GLP |
| 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs |
| 21 CFR 11, 58, 210/211, 820 - Master GMP Trainer: Guidance Doc. GMPs for the 21st Century & Quality Syst. Approach to GMPs |
| 21 CFR 11, 58, 210/211, 820, ICH E6(R2) - GMP 2 Combination Handbook |
| 21 CFR 11, 58, 820 - Electronic Records with GLP and QSR |
| 21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs |
| 21 CFR 11, 820 - Electronic Records with Quality Systems Regulations |
| 21 CFR 11, 820 QSR and 830 UDI |
| 21 CFR 13 - Public Hearing |
| 21 CFR 50 - Protection of Human Subjects |
| 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
| 21 CFR 54 - Financial Disclosure by Clinical Investigators |
| 21 CFR 56 - Institutional Review Boards |
| 21 CFR 58 - Good Laboratory Practice |
| 21 CFR 58, 606 - Good Laboratory Practice for Blood Industry |
| 21 CFR 58, 820 - GLP and QSR |
| 21 CFR 101, 110 and 117 - Food Labeling Combination |
| 21 CFR 106, 107, 110 and 117 - Infant Formula Regulations |
| 21 CFR 108, 110, 113, 114 and 117 - GMPs for Low-Acid Foods |
| 21 CFR 110, 117, 130, 131, 133 - Milk and Dairy |
| 21 CFR 111 - Dietary Supplement handbook |
| 21 CFR 112 Produce for Human Consumption |
| 21 CFR Part 112 Produce and 117 Food GMPs |
| 21 CFR 115 and 118 Egg Products |
| 21 CFR 200 - General Drug |
| 21 CFR 200, 201 - General Drug & Drug Labeling Combination |
| 21 CFR 203 - Prescription Drug Marketing |
| 21 CFR 205 - Guidelines for Licensing of Wholesale Drug |
| 21 CFR 210/211 - Drug GMPs |
| 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 GMP Audit Check List |
| 21 CFR 210/211 with Keyword Index |
| 21 CFR 312 - Investigational New Drug Application |
| 21 CFR 312, 314, 511 - Human and Animal Drug Approval |
| 21 CFR 314 - Applications for FDA Approval to Market a New Drug |
| 21 CFR 316 - Orphan Drugs |
| 21 CFR 320 - Bioavailability and Bioequivalence Requirements |
| 21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
| 21 CFR 600 - Biological Products: General |
| 21 CFR 600, 601, 610 - Biologic GMP |
| 21 CFR 601 - Licensing - Biologics |
| 21 CFR 606 - Blood Industry |
| 21 CFR 610 - General Biological Products Standards |
| 21 CFR 640 - Add. Standards for human blood and blood products |
| 21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests |
| 21 CFR 680 - Additional Standards for Miscellaneous Products |
| 21 CFR 801 - Labeling - Medical Device |
| 21 CFR 803 - Medical Device Reporting |
| 21 CFR 806 - Medical Devices; Reports of Corrections and Removal |
| 21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
| 21 CFR 809 - In-Vitro Diagnostic Products |
| 21 CFR 810 - Medical Device Recall Authority |
| 21 CFR 812 - Investigational Device Exemptions |
| 21 CFR 814 - Premarket Approval of Medical Device |
| 21 CFR 820 - Quality System Regulations |
| 21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH |
| 21 CFR 820 - Quality System Regulations-SPANISH |
| 21 CFR Part 117 - Food GMPs |
| 21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products |
| 30 Day Posting Pack |
| 503B Compounding Master Guide |
| 510k and PMA Guidelines |
| Canadian GMP Guidelines GUI-0001 July 1, 2020 |
| Chinese GMPs - NMPA - State Food & Drug Administration P.R. CHINA |
| Clinical Master Reference Guide |
| Dietary Supplement Master Handbook |
| Electronic Systems Master Handbook 1 |
| 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 and US GMPs with Q7 API |
| EU GMPs Chapter 1 - 9 |
| EU GMPs with Annex 1 Sterile Medicinal Products |
| EU GMPs with Annex 10 Inhalation Products |
| EU GMPs with Annex 11 Computerized Systems |
| EU GMPs with Annex 11, 15 - Computerized Systems and Validation |
| EU GMPs with Annex 11, 15, 16 and ICH Q7 |
| EU GMPs with Annex 11, 15, 16, 18, 19 |
| EU GMPs with Annex 12 Ionizing Radiation |
| 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 17 Parametric Release |
| EU GMPs with Annex 19 Reference and Retention Samples |
| EU GMPs with Annex 2 Biological |
| EU GMPs with Annex 3 RadioPharma |
| EU GMPs with Annex 4 Vet. products other than Immuno |
| EU GMPs with Annex 5 Immunolgical Vet. Products |
| EU GMPs with Annex 6 Manufacture of Medicinal Gases |
| 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 |
| EU GMPs with ICH Q7, Q8(R2), Q9(R1) and Q10 |
| Eudralex - Pharmacovigilance for Medical Products Volume 9a |
| FDA DEA GMP Master Reference Guide |
| GLP Master Handbook |
| GMP - PAT Handbook |
| GMP International Master Reference Guide |
| GMP Medical Device Master Reference Guide |
| ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| ICH E4 - Dose-Response Information to Support Drug Registration |
| ICH E6(R2) - Good Clinical Practice |
| ICH E8 - General Considerations for Clinical Studies |
| ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
| ICH Q10 - Pharmaceutical Quality System |
| ICH Q1A(R2) - Stability Testing of New Drug Substances and Products |
| ICH Q1E - Evaluation of Stability Data |
| ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology |
| ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
| 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 |
| ICH Q7, Q8(R2), Q9(R1), Q10 and Q11 |
| ICH Q8(R2) - Pharmaceutical Development |
| ICH Q9(R1) - Quality Risk Management |
| ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
| ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals |
| In Vitro Diagnostics 2017/746 Medical Devices |
| In Vitro Diagnostics Master Handbook |
| Japanese GMP for Drugs and Quasi-drugs - 2005 |
| Medical Device Clinical with EU Directive |
| Medical Device Combination 2 - 21 CFR Part 11, Part 820 and EU 2017/745 |
| Medical Device QSIT Manual with 11 and 820 |
| Medical Device QSIT Manual with 11, 803, 806, 820 and 821 |
| Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist |
| Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
| Medical Device Quality Systems Manual with 820 and QSR Audit Checklist |
| Title 21 CFR Parts 1 - End Nine Volume Set |
| US and Canadian GMPs with ICH Q7, Q8(R2), Q9(R1), Q10 |
| US, EU and Canadian Medical Device Combination |
| US, EU and Japanese GMPs |
| VICH GL9 Animal GCP |
| GMP Boot Camp Certificate and GMP Handbook |
| 21 CFR Parte 117 - cGMPs for Human Food - SPANISH |
| 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 |
| ICH Q12 Pharmaceutical Product Lifecycle Management |
| 21 CFR 112 - Produce for Human Consumption - SPANISH |
| 21 CFR 117 - cGMPs for Human Food - ENGLISH/SPANISH |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 |
| 21 CFR Parts 112 and 117 - ENGLISH/SPANISH |
| ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination |
| Standard Sterile Product Manufacturing Handbook |
| 21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH |
| EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products |
| GMP Manufacturing Handbook |
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