Statistical Implications of the CGMPs: A 30-Year Retrospective - Pharmaceutical Technology

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Statistical Implications of the CGMPs: A 30-Year Retrospective
This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.


Pharmaceutical Technology


13. ICH Q6A Specification: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances and ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (International Conference on Harmonization, 1999).

14. ICH Q8 Pharmaceutical Development (International Conference on Harmonization, Geneva, Switzerland, 2006)

15. ICH Q9 Quality Risk Management (International Conference on Harmonization, Geneva, Switzerland, 2006)

16. FDA/CDER/CVM/ORA, Guidance for Industry:PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, 2004).


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