Regulatory and Quality Considerations for Continuous Manufacturing
Category
Published on CMKC
Abstract
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.
Journal
Journal of Pharmaceutical Sciences. Volume 104, 2015, 803-812
DOI
10.1002/jps.24324
Type of publication
Peer-reviewed journal
Affiliations
- Pfizer Inc
- Novartis Pharma
- Massachusetts Institute of Technology (MIT) (MIT), FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), Roche, GlaxoSmithKline, Vertex, AstraZeneca, Jansen, Norwegian Medicines Agency, Luxembourg National Health Laboratory
Article Classification
Research article
Classification Areas
- PAT
- Regulatory