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References - Pharmaceutical GMP Professional Certification - CPGP

References

  • 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.

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