Stage 2A and Stage 2B: Process Qualification
The process qualification stage verifies that the commercial process developed is capable of reproducible commercial manufacturing. Stage 2 is required prior to product commercialization and establishes the process with scientific evidence that it is capable of consistently delivering quality drug products. Qualification activities for facility, equipment, and utilities (Stage 2A) are conducted prior to use in commercial Stage 2B activities.
KeywordsProcess qualification Stage 2A Stage 2B Commercial distribution Statistical assessment acceptance criteria FDA
- 1.Tartal J. Quality system regulation process validation FDA small business regulatory education for industry (REdI), Silver Spring, MD. 2015.Google Scholar
- 2.ISPE. Commissioning and qualification baseline guide. Tampa: ISPE; 2018.Google Scholar
- 3.Drapala P. Deviation investigation format and content: a guide for inspection success. Pharm Technol. 2017;41:108–10.Google Scholar
- 4.ISPE. Good engineering practices (GEP). Tampa: ISPE; 2008.Google Scholar
- 5.JVT. ASTM E2500: the end of validation? J Valid Technol. 2014. http://www.ivtnetwork.com/article/astm-e2500-end-validation.
- 6.ASTM. E2500: standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment. Philadelphia: ASTM; 2013.Google Scholar
- 8.US FDA. Guidance for industry PAT – a framework for innovative pharmaceutical development, manufacturing, and quality assurance, Pharmaceutical CGMP. 2004.Google Scholar
- 9.ISPE. Process validation conference, Bethesda. 12–14 Sept 2017.Google Scholar