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