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Pharmaceutical GMP Professional Certification CPGP

References - Pharmaceutical GMP Professional Certification - CPGP

References

Code of Federal Regulations 21CFR (including FDA Preamble [Fed Register Vol. 43 No. 190] ) documents

  • 210-211 Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding Finished Pharmaceuticals
  • Section 7 Recalls (Including Product Corrections)
  • Part 11 Electronic Records ; electronic signatures
  • Part 58 Good Laboratory Practices for Non-clinical Laboratory Studies
  • 1308.11-1308.15 requirement for storage of controlled substances
  • 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors

Food and Drug Administration (FDA) Guidances

  • Changes to an Approved NDA or ANDA
  • Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
  • Container Closure Systems for Packaging Human Drugs and Biologics
  • Current Good Manufacturing Practice for Combination Products
  • for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
  • General Principles of Software Validation
  • Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment
  • Product Recalls, Including Removals and Corrections
  • Q1A (R2) Stability Testing of New Drug Substances and Products
  • Q1E Evaluation of Stability Data
  • Q3B( R) Impurities in New Drug Products
  • Quality Systems Approach to Pharmaceutical CGMP Regulations
  • Sterile Drug Products Produced by Aseptic Processing

FDA Guide to Inspections

  • Investigations Operations Manual (IOM) 2008
  • Microbiological Pharmaceutical Quality Control Laboratories
  • Pharmaceutical Quality Control Laboratories
  • Topical Drug Products
  • Validation of Cleaning Processes
  • High Purity Water Systems
  • Biotechnology inspection guide reference materials and training aids

FDA Guidelines

  • Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs 
  • Validation of the Limulus Amebocyte Lysate Test
  • Inspections of Sterile Drug Substance Manufacturers
  • Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation
  • Investigating Out of Specification Test Results
  • General Principles of Process Validation

FDA Policy Guides (Compliance Policy Guides (CPG))

  • Preapproval Inspections 7346.832
  • Sterile Drug Process Inspections Program 7356.002A
  • Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program 7356.002
  • Compliance Program Guidance Manual 7356.002F Active Pharmaceutical Ingredient (API) Process Inspection

Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S)

  • PE 008-2 Explanatory Notes for Industry on the Preparation of a Site Master File
  • PE 010-3 PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
  • Pl 006-3 Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
  • Pl 007-4 Recommendation on the Validation of Aseptic Processes
  • Pl 009-3 Aide-Memoire on Inspection of Utilities
  • Pl 010-3 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
  • Pl 011-3 Good Practices for computerized systems in regulated “GXP” environments
  • Pl 012-3 Recommendation on Sterility Testing
  • Pl 014-3 Recommendation on Isolators Used for Aseptic Processing and Sterility Testing

American National Standards Institute (ANSI)/International Organization for Standards (ISO)

  • ANSI/ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
  • ISO 19011:2002 Guidelines for Quality and Environmental Management Systems Auditing
  • ISO 9001-2000 Quality Management Systems Requirements

Directives

  • Directive 2001/82/EC on the Community Code Relating to Veterinary Medicinal Products
  • Directive 2003/94/EC Laying Down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human and Investigational Medicinal Products for Human Use as amended
  • Directive 2001/83/EC on the Community Code Relating to human medicinal products

European Good Manufacturing Practice

  • Eudralex Volume 4, Parts I and II and Annexes

Health Canada Guidelines

  • 0069 Guidelines for Temperature Control of Drug Products During Storage and Transportation
  • Good Manufacturing Practices Guidelines

International Conference on Harmonization (ICH) Documents

  • ICH Q10 Harmonized Tripartite Guideline--Pharmaceutical Quality System
  • ICH Q7 Good Manufacturing Guide for Active Pharmaceutical Ingredients
  • ICH Q9 Quality Risk Management
  • ICH Q10 Pharmaceutical Quality System
  • ICH Q2A Text on Validation of Analytical Procedures
  • ICH Q2B Validation of Analytical Procedures: Methodology
  • ICH Q3A Impurities in New Drug Substances
  • ICH Q3C Impurities: Guideline for Residual Solvents
  • ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
  • ICH Q8 Pharmaceutical Development

International Society for Pharmaceutical Engineering (ISPE) Guidelines

  • ISPE GAMP IV and V (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems

U.S. Drug Enforcement Agency (DEA)

  • 21 USC Sec. 812: L.91-513 Controlled substances act

Parenteral Drug Association (PDA) Technical Reports

  • Report No. 1 Validation of Steam Sterilization Cycles

Japan

  • Pharmaceutical Administration, Regulation and Drug Development in Japan

European Pharmacopeia

  • 2.2.44 Total Organic Carbon in Water for Pharmaceutical Use
  • 2.2.46 Chromatographic Separation Techniques
  • 2.6.7 Mycoplasmas

Australian Guidelines

  • TGA Guidelines for Sterility Testing of Therapeutic Goods
  • TGA Amended EU (EMEA/410/01) Guideline Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products

United States Pharmacopeia (USP)

  • General chapters related to pharmaceutical analytical methods and practices

World Health Organization (WHO) documents

  • Good Manufacturing Practices (A Compendium of Guidelines and Related Materials Volume 2: Good Manufacturing Practices and Inspection)
  • QAS/04.068/Rev. 2 Good Distribution Practices for Pharmaceutical Products
  • Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, 2004 WHO

FDA Center for Biologics Evaluation & Research (CBER) Guidances

  • Bioanalytical Method Validation
  • Biological Indicator (BI) Premarket Notification [510(k)] Submissions
  • Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components
  • Characterization and Qualification of Cell Substrates and Other Biological Starting Mat’ls Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
  • Points to Consider (PTC) in the Characterization of Cell Lines Used to Produce Biologicals
  • Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
  • Q5E Comparability of Biotechnological/Biological Product Subject to Changes in their Manufacturing Process

9CFR and 21CFR documents (related to biologics)

  • 9 CFR Parts related to Animal Biologics Quality Requirements in Manufacturing
  • 21 CFR 601 Licensing
  • 21 CFR 600 Biological Products: General
  • 21 CFR 610 selected sections critical to biologic drugs

Compliance Policy Guides (CPGs)

  • CPG 7345.848 Inspection of Biological Drug Products
  • Guide to Inspections of Lyophilization of Parenterals

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