Book References and Official Source Links
This page provides official-source links for the regulations, guidance documents, standards, compendial chapters, and technical publications referenced in Practical GMP Validation. The identifiers shown here correspond directly to those used throughout the book and in Appendix L.
Source documents may be revised, replaced, reaffirmed, or withdrawn. Confirm the current edition and its applicability before using any source for a regulated decision. Access to certain standards and compendial publications may require purchase or subscription.
Regulations
REG-01 — Federal Food, Drug, and Cosmetic Act, Section 501(a)(2)(B)
United States Congress. Statutory foundation for current good manufacturing practice requirements.
Official source
REG-02 — 21 CFR Part 11, Electronic Records; Electronic Signatures
Electronic Code of Federal Regulations.
Official source
REG-03 — 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
Electronic Code of Federal Regulations.
Official source
REG-04 — 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals
Electronic Code of Federal Regulations.
Official source
REG-05 — 21 CFR Part 4, Regulation of Combination Products
Electronic Code of Federal Regulations.
Official source
REG-06 — 21 CFR Parts 600–680, Biological Products
Electronic Code of Federal Regulations.
Official source
REG-07 — 21 CFR Part 820, Quality Management System Regulation
Electronic Code of Federal Regulations.
Official source
REG-08 — EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice
European Commission. Current consolidated text and annexes.
Official source
REG-09 — EudraLex Volume 4, Annex 1, Manufacture of Sterile Medicinal Products
European Commission, 2022.
Official source
REG-10 — EudraLex Volume 4, Annex 11, Computerised Systems
European Commission.
Official source
REG-11 — EudraLex Volume 4, Annex 15, Qualification and Validation
European Commission, 2015.
Official source
REG-12 — Federal Food, Drug, and Cosmetic Act, Section 503B, Outsourcing Facilities
United States Congress. 21 U.S.C. 353b.
Official source
FDA Guidance and Technical Resources
FDA-01 — Process Validation: General Principles and Practices
U.S. Food and Drug Administration. Guidance for Industry, January 2011.
Official source
FDA-02 — Data Integrity and Compliance With Drug CGMP: Questions and Answers
U.S. Food and Drug Administration. Guidance for Industry, December 2018.
Official source
FDA-03 — Part 11, Electronic Records; Electronic Signatures—Scope and Application
U.S. Food and Drug Administration. Guidance for Industry, August 2003.
Official source
FDA-04 — Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
U.S. Food and Drug Administration. Guidance for Industry, September 2006.
Official source
FDA-05 — Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice
U.S. Food and Drug Administration. Guidance for Industry, September 2004.
Official source
FDA-06 — General Principles of Software Validation
U.S. Food and Drug Administration. Final Guidance for Industry and FDA Staff, Version 2.0, January 2002.
Official source
FDA-07 — Analytical Procedures and Methods Validation for Drugs and Biologics
U.S. Food and Drug Administration. Guidance for Industry, July 2015.
Official source
FDA-08 — Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
U.S. Food and Drug Administration. Guidance for Industry, November 1994.
Search FDA guidance documents
FDA-09 — Guide to Inspections of Validation of Cleaning Processes
U.S. Food and Drug Administration, July 1993.
Official source
FDA-10 — Guide to Inspections of Computerized Systems in Drug Processing
U.S. Food and Drug Administration, February 1983.
Official source
FDA-11 — Questions and Answers on Current Good Manufacturing Practice Requirements—Records and Reports
U.S. Food and Drug Administration. Current web publication.
Official source
FDA-12 — Quality Essentials: Inspectional Coverage of Quality Management Systems and Data Integrity
U.S. Food and Drug Administration.
Official source
FDA-13 — Investigating Out-of-Specification Test Results for Pharmaceutical Production
U.S. Food and Drug Administration. Guidance for Industry, May 2022.
Official source
FDA-14 — Questions and Answers on Current Good Manufacturing Practice Requirements: Equipment
U.S. Food and Drug Administration. Current web publication.
Official source
FDA-15 — Questions and Answers on Current Good Manufacturing Practice Regulations: Production and Process Controls
U.S. Food and Drug Administration. Current web publication.
Official source
ICH Guidance
ICH-01 — ICH Q2(R2), Validation of Analytical Procedures
International Council for Harmonisation, November 2023.
ICH-02 — ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
International Council for Harmonisation, November 2000.
ICH-03 — ICH Q8(R2), Pharmaceutical Development
International Council for Harmonisation, August 2009.
ICH-04 — ICH Q9(R1), Quality Risk Management
International Council for Harmonisation, January 2023.
ICH-05 — ICH Q10, Pharmaceutical Quality System
International Council for Harmonisation, June 2008.
ICH-06 — ICH Q11, Development and Manufacture of Drug Substances
International Council for Harmonisation, May 2012.
ICH-07 — ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
International Council for Harmonisation, November 2019.
ICH-08 — ICH Q14, Analytical Procedure Development
International Council for Harmonisation, November 2023.
Official ICH Quality Guidelines
Consensus Standards
Complete standards may require purchase from the issuing organization.
STD-01 — ASTM E2500-25, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM International, 2025.
Official publisher record
STD-02 — ISO 14644-1:2015, Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness by Particle Concentration
International Organization for Standardization.
Official publisher record
STD-03 — ISO 14644-2:2015, Cleanrooms and Associated Controlled Environments—Part 2: Monitoring to Provide Evidence of Cleanroom Performance Related to Air Cleanliness by Particle Concentration
International Organization for Standardization.
Official publisher record
STD-04 — ISO 14644-3:2019, Cleanrooms and Associated Controlled Environments—Part 3: Test Methods
International Organization for Standardization.
Official publisher record
STD-05 — ISO 14644-4:2022, Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction and Start-Up
International Organization for Standardization.
Search the official ISO catalogue
STD-06 — ISO 13485:2016, Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
International Organization for Standardization.
Official publisher record
STD-07 — ISO 14971:2019, Medical Devices—Application of Risk Management to Medical Devices
International Organization for Standardization.
Official publisher record
STD-08 — ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories
International Organization for Standardization and International Electrotechnical Commission.
Official publisher record
STD-09 — ISO 11138 Series, Sterilization of Health Care Products—Biological Indicators
International Organization for Standardization. Applicable current parts.
Search the official ISO catalogue
STD-10 — ISO 17665:2024, Sterilization of Health Care Products—Moist Heat—Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
International Organization for Standardization.
Search the official ISO catalogue
Compendial Sources
Complete USP–NF general chapters may require subscription access.
COMP-01 — USP General Chapter <1058>, Analytical Instrument Qualification
United States Pharmacopeia. Current USP–NF edition.
COMP-02 — USP General Chapter <1220>, Analytical Procedure Life Cycle
United States Pharmacopeia. Current USP–NF edition.
COMP-03 — USP General Chapter <1224>, Transfer of Analytical Procedures
United States Pharmacopeia. Current USP–NF edition.
COMP-04 — USP General Chapter <1225>, Validation of Compendial Procedures
United States Pharmacopeia. Current USP–NF edition.
COMP-05 — USP General Chapter <1226>, Verification of Compendial Procedures
United States Pharmacopeia. Current USP–NF edition.
Technical Sources
TECH-01 — GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition
International Society for Pharmaceutical Engineering, 2022.
Official ISPE publications catalogue
TECH-02 — ISPE Baseline Guide, Volume 5: Commissioning and Qualification, Second Edition
International Society for Pharmaceutical Engineering, 2019.
Official ISPE publications catalogue
TECH-03 — PI 041-1, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Pharmaceutical Inspection Co-operation Scheme, July 2021.
Official PIC/S publications
TECH-04 — WHO Technical Report Series No. 1019, Annex 3, Guidelines on Validation
World Health Organization, 2019.
Official WHO publication
TECH-05 — PDA Technical Report No. 29, Points to Consider for Cleaning Validation
Parenteral Drug Association. Revised 2012.
Official PDA bookstore
Link Maintenance
The links on this page are maintained as a reader service. A link may be updated when a publisher moves, revises, or replaces a source document. Updating a link does not change the reference identifier assigned in the book.
Questions or corrections concerning these references may be submitted through the US Validation Services contact page.
Last reference review: September 24, 2026