| Select Book Parts - If Parts not listed, add Regulations or Guidance within the Comments Section Below: |
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| US FDA Regulations |
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21 CFR 3 - Product Jurisdiction |
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21 CFR 4 -Regulation of Combination Products |
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21 CFR 7 - Enforcement Policy |
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21 CFR 11 - Electronic Records with Scope and Application |
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21 CFR 11 - Electronic Records with Computerized Systems used in Clinical Investigations |
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21 CFR 11 - Electronic Records with Scope and Application and Preambles |
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21 CFR 11 - Electronic Records with Part 11 Checklist |
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21 CFR 11 - Electronic Records - Spanish Translation |
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21 CFR 13 - Public Hearing |
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21 CFR 16 - Regulatory hearing before the Food and Drug Administration |
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21 CFR 50 - Protection of Human Subjects |
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21 CFR 54 - Financial Disclosure by Clinical Investigators |
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21 CFR 56 - Institutional Review Boards |
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21 CFR 58 - Good Laboratory Practice |
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21 CFR 101 - Food Labeling |
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21 CFR 106 - Infant Formula Quality Control Procedures |
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21 CFR 107 - Infant Formula |
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21 CFR 108 - Emergency Permit Control |
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21 CFR 110 - Current Good Manufacturing Practice, in Manufacturing, Packing, or Holding Human Food |
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21 CFR 110 - Food GMPs - Spanish Translation |
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21 CFR 111 - Dietary Supplement handbook |
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21 CFR 112 - Stds for Growing, Harvesting, Packing, and Holding of Produce... |
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21 CFR 112 - Spanish Translation |
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21 CFR 113 - Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers |
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21 CFR 114 - Acidified Foods |
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21 CFR 115 - Shell Eggs |
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21 CFR 117 - CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food |
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21 CFR 117 - Spanish Translation |
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21 CFR 118 - Production, Storage, and Transportation of Shell Eggs |
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21 CFR 120 - Hazard Analysis and Critical Control Point (HACCP) Systems |
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21 CFR 121 - Mitigation Strategies to Protect Food Against Intentional Adulteration |
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21 CFR 123 - Fish and Fishery Products |
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21 CFR 129 - Processing and Bottling of Bottled Drinking Water |
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21 CFR 130 - Food standards: General |
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21 CFR 131 - Milk and Cream |
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21 CFR 133 - Cheeses and Related Cheese Products |
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21 CFR 200 - General Drug |
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21 CFR 201 - Drug Labeling |
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21 CFR 203 - Prescription Drug Marketing |
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21 CFR 205 - Guidelines for State Licensing of Wholesale Prescription Drug Distributors |
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21 CFR 207 - Req. for Foreign and Domestic Establishment Registration... |
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21 CFR 210/211 - Drug GMPs |
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21 CFR 210/211 - Drug GMPs - Spanish Translation |
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21 CFR 210/211 - with Drug Preambles |
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21 CFR 210/211 - with GMP Audit Check List |
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21 CFR 210/211 - with Keyword Index |
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21 CFR 225 - Current Good Manufacturing Practice for Medicated Feeds |
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21 CFR 312 - Investigational New Drug Application |
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21 CFR 314 - Applications for FDA Approval to Market a New Drug |
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21 CFR 316 - Orphan Drugs |
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21 CFR 320 - Bioavailability and Bioequivalence Requirements |
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21 CFR 507 - CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
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21 CFR 511 - New Animal Drugs For Investigational Use |
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21 CFR 600 - Biological Products: General |
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21 CFR 601 - Licensing - Biologics |
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21 CFR 606 - CGMPs for Blood and Blood Components |
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21 CFR 607 - Establishment Registration ... Human Blood and Blood Products |
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21 CFR 610 - General Biological Products Standards |
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21 CFR 630 - General Requirements for Blood, Blood Components, and Blood Derivatives |
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21 CFR 640 - Additional Standards for Human Blood and Blood Products |
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21 CFR 660 - Additional Standards for Diagnostic Substances for Laboratory Tests |
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21 CFR 680 - Additional Standards for Miscellaneous Products |
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21 CFR 700 - Cosmetic-General |
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21 CFR 701 - Cosmetic-Labeling |
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Cosmetic - Is It Soap or a Drug Guidance |
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21 CFR 801 - Labeling - Medical Device |
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21 CFR 803 - Medical Device Reporting |
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21 CFR 806 - Medical Devices; Reports of Corrections and Removal |
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21 CFR 807 - Establishment Registration ... for Manufacturers and Initial Importers of Devices |
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21 CFR 808 - Exemptions from Federal Preemption of State and Local Medical Device Requirements |
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21 CFR 809 - In-Vitro Diagnostic Products |
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21 CFR 810 - Medical Device Recall Authority |
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21 CFR 812 - Investigational Device Exemptions |
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21 CFR 814 - Premarket Approval of Medical Device |
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21 CFR 820 - Quality System Regulations |
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21 CFR 820 - with Quality System Regulations (QSR) Audit Checklist |
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21 CFR 820 - Quality System Regulations - Spanish Translation |
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21 CFR 820 - Quality System Regulations - Chinese Translation |
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21 CFR 821 - Medical Device Tracking Requirements |
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21 CFR 822 - Postmarket Surveillance |
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21 CFR 830 - Unique Device Identification |
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21 CFR 860 - Medical Device Classification Procedures |
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21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue Based Products |
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| Other US CFRs |
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40 CFR 160 - Good Laboratory Practice Standards |
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42 CFR 493 - Laboratory Requirements |
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45 CFR 46 - Protection of Human Subjects |
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45 CFR 160 - General Administrative Requirements |
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45 CFR 162 - Administrative Requirements |
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| EU GMPs and Annexes |
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EU GMPs - Chapter 1 - 9 |
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Annex 1 Manufacture of Sterile Medicinal Products - August 2023 |
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Annex 2 Manufacture of Biological Medical Products for Human Use |
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Annex 3 Manufacture of Radiopharmaceuticals |
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Annex 4 Manufacture of Veterinary Medical Products |
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Annex 5 Manufacture of Immunological Veterinary Medical Products |
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Annex 6 Manufacture of Medicinal Gases |
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Annex 7 Manufacture of Herbal Medicinal Products |
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Annex 8 Sampling of Starting and Packaging Materials |
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Annex 9 Manufacture of Liquids, Creams and Ointments |
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Annex 10 Inhalation Products |
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Annex 11 Computerized Systems |
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Annex 12 Ionizing Radiation |
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Annex 13 Investigational medicinal Products |
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Annex 14 Human Blood or Plasma Products |
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Annex 15 Qualification and Validation |
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Annex 16 Qualified Person and Batch Release |
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Annex 17 Parametric Release |
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Annex 19 Reference and Retention Samples |
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EU Medical Device Regulation MDR 2017-745 (replaced 93/42/EEC) |
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EU Medical Device Regulation IVD 2017-746 |
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EU ATMPs -Good Manufacturing Practice specific to Advanced Therapy Medicinal Products |
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| Canadian |
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Canadian GMP - Good Manufacturing Practices (GMP) Guidelines 2020 EDITION GUI-0001 |
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Canadian GCP - Drugs for Clinical Trials Involving Human Subjects |
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Canadian - Annex 2 to the Current Edition of the GMP Guidelines: Manufacture of Drugs Used in Clinical Trials |
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Canadian - SOR/98-282 Medical Devices Regulations |
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| ICH Guidance |
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ICH E2A - Clinical Safety Data Management |
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ICH E2B(R3) - Clinical Safety Data Management |
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ICH E4 - Dose-Response Information to Support Drug Registration |
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ICH E6 - Good Clinical Practice |
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ICH E8 - General Considerations for Clinical Trials |
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ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials...Pharmaceuticals |
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ICH M10 - Bioanalytical Method Validation and Study Sample Analysis |
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ICH Q1A(R2) - Stability Testing of New Drug Substances and Products |
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ICH Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products |
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ICH Q1C - Stability Testing for new Dosage Forms |
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ICH Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug... |
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ICH Q1E - Evaluation of Stability Data |
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ICH Q2(R2) - Analytical Validation |
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ICH Q3A(R2) - Impurities in New Substances |
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ICH Q3B(R2) - Impurities in New Products |
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ICH Q3C(R5) - Impurities: Guideline for Residual Solvents |
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ICH Q5A(R2) - Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human and Animal Origin |
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ICH Q5B - Analysis of the Expression Construct in Cell Usage for Production of r-DNA Derived Protein Products |
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ICH Q5C - Stability Testing of Biotechnological / Biological Products |
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ICH Q5D - Derivation and Characterization of Cell Substrates Used for Products of Biotechnological / Biological Products |
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ICH Q5E - Comparability of Biotechnological / Biological Products Subject to Changes in their Manufacturing Process |
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ICH Q6A - Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances |
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ICH Q6B - Specifications: Test Procedures and Acceptance Biotechnological / Biological Products |
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ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients |
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ICH Q8(R2) - Pharmaceutical Development |
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ICH Q9(R1) - Quality Risk Management |
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ICH Q10 - Pharmaceutical Quality System |
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ICH Q11- Development and Manufacture of Drug Substances |
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ICH Q12 - Pharmaceutical Product Lifecycle Management |
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ICH Q8/9/10 (R4) - Questions and Answers |
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ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals |
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ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
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ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals |
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| Japanese JPAL |
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Japanese GMP for Drugs and Quasi-drugs - 2005 |
| Chinese NMPA |
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Chinese Decree 79 GMP for Drugs |
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Chinese Decree 64 GMP for Medical Device |
| Guidance |
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Pharmaceutical CGMPS for the 21st Century - A RISK-BASED APPROACH |
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Computerized Systems Used in Clinical Investigations |
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Guideline on General Principles of Process Validation |
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Definition of a Combination Product |
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Compliance Program Guidance Manual for FDA Staff |
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Inspection of Medical Device Manufacturers Document issued on: June 15, 2006 Program 7382.845 |
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GMP - PAT Handbook |
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Drug Manufacturing Inspections |
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Program 7356.002 |
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EU Clinical Trials Directive |
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Medical Device Quality Systems Manuel |
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Medical Device Reporting for Manufacturers |
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OECD General Principal 1 |
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PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance |
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Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice |
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General Principles of Software Validation |
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Quality Systems Approach to Pharmaceutical CGMP Regulations |
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Medical Device QSIT Manual |
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PMA Premarket Approval |
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510k Guidelines |
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If Parts are not listed above, add here, along with any customizations requested.
You can also email all custom pages to sales@gmppublications.com |
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