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GMP Publications - Code of Federal Regulation Handbooks by the FDA

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