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.

• 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

• PAT
• Regulatory

1. continuous manufacturing
2. Control strategy / Unit operations / Stability / Processing
3. GMP
4. ICH
5. pat
6. regulatory
7. Regulatory considerations
8. Research Article
9. Validation