Statistical Issues in Process Validation of Pharmaceutical Products

• Activity Number: 522
• Type: Roundtables
• Date/Time: Wednesday, August 6, 2014 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Katherine E.D. Giacoletti*+ and Stan Altan
• Companies: McNeil Consumer Healthcare/Johnson & Johnson and Janssen
• Keywords: process validation ; process qualification ; pharmaceutical manufacturing ; statistical process control ; regulatory statistics ; quality risk management

Abstract

This roundtable discussion is related to the contributed session on the same topic. Specifically, the 2011 FDA guidance Process Validation: General Principles and Practices contains a comprehensive discussion of the FDA's current thinking. Process validation (PV) is framed as a lifecycle activity, rather than a static event, requiring connecting the knowledge gained during development to commercial manufacturing in a meaningful way. It seeks to promote the application of sound science. These new requirements present challenges to industry and opportunities for statisticians to have substantial impact. Consequently, statisticians and the pharmaceutical industry would benefit from dialogues exploring the implications of the guidance on best statistical practices in this context.