References
These books cover various parts of the CPGP Body of Knowledge. The ASQE Certification Council does not endorse any one particular reference source.
- ANSI/ISO/ASQ Q9001-2008: Quality Management Systems: Requirements
- Bioanalytical Method Validation 2018
- Code of Federal Regulations (CFR) Title 21
- Code of Federal Regulations 21 CFR
- Directive 2001/83/EC on the Community Code Relating to human medicinal products
- Durivage, Mark A., The Certified Pharmaceutical GMP Professional Handbook, 2nd ed. Milwaukee, WI: ASQ Quality Press, 2016.
- Eudralex Volume 4, Parts I and II and Annexes
- FDA Guidances
- FDA Guide to Inspections
- Food and Drug Administration (FDA) Guidances Quality Systems Approach to Pharmaceutical CGMP Regulations
- General chapters related to pharmaceutical analytical methods and practices
- Good Manufacturing Practices (A Compendium of Guidelines and Related Materials Volume 2: Good Manufacturing Practices and Inspection)
- Griffith, Gary K., The Quality Technician’s Handbook, 6th ed., New Jersey: Pearson Education, 2013.
- Guidance for Industry: PAT- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products
- Hazard Analysis and Critical Control Point Principles and Application Guidelines, Adopted, August 14, 1997 National Advisory Committee on Microbiological Criteria for Foods (NACMCF)
- Health Canada Guidelines 0069 Guidelines for Temperature Control of Drug Products During Storage and Transportation
- Health Canada Guidelines Good Manufacturing Practices Guidelines
- ICH Quality Guidelines
- IPEC GMP Guide for Pharmaceutical Excipients
- Note for Guidance on Quality of Water for Pharmaceutical Use
- PDA Technical Report No. 26
- PIC/S Aide-Memoires
- PIC/S GMP Guide Part 1, Part 2 and Annexes, PE 009-10
- PIC/S Guidance Documents
- PIC/S Site Master File Documents
- Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials, 2004 WHO
- Report No. 30 Parametric release of Pharmaceutical and Medical device products terminally sterilized by moist heat
- Standardized Numerical Identification for Prescription Drug Packages
- 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
- WHO Expert Committee on Specifications for Pharmaceutical Preparations
- World Health Organization (WHO) Publications
ASQ books are available from ASQ Quality Press.