As QbD (Quality by Design*)-based approaches are being widely adopted in pharmaceutical development, manufacturing and control, emerging technologies are being increasingly introduced into pharmaceutical manufacturing.
The purpose of this WG is to discuss regulatory issues related to quality assessment and GMP inspection to facilitate the introduction of innovative manufacturing technologies while ensuring appropriate quality.
Continuous manufacturing is our primary target.
* Quality by Design; A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
Office of New Drug I-V (Quality)
Office of Cellular and Tissue-based Products
Office of Generic Drugs
Office of Manufacturing/Quality and Compliance
Office of Research Promotion
|Dec. 2020||Update on ICH Q13||ISPE Singapore Affiliate Conference and Exhibition 2020, Singapore (Web)|
|Apr. 2019||PMDA Perspective||The 4th FDA/PQRI Conference on Advancing Products Quality, Rockville, USA|
|Dec. 2018||The Landscape of Continuous Manufacturing in Japan||CMC Strategy Forum Japan 2018,Tokyo|
|Nov. 2018||Current Regulatory Considerations and Challenges for Continuous Manufacturing of Pharmaceuticals||15th DIA Japan Annual Meeting 2018,Tokyo|
|Oct. 2018||PMDA Update||3rd International Symposium on Continuous Manufacturing of Pharmaceuticals, London, UK|
|Jun. 2018||PMDA Activities for Implementation of Continuous Manufacturing||2018 ISPE Continuous Manufacturing Workshop, Arlington, USA|
|May. 2018||The landscape of continuous manufacturing in Japan||2018 Annual Meeting ISPE Japan Affiliate,Tokyo,Japan|
|Mar. 2018||Current Regulatory Considerations for Continuous Manufacturing of Pharmaceuticals in Japan||2018 PDA Annual Meeting, Orlando, USA|
|Feb. 2018||CM Research Outcomes||IFPAC 2018, Bethesda, USA|
|May. 2017||PMDA’s Perspectives on Continuous Manufacturing||2017 Annual Meeting 15th Anniversary ISPE Japan Affiliate, Toyama, Japan|
|Apr. 2017||PMDA Update||DIA CMC Workshop, Rockville, USA|
|Mar. 2017||PMDA’s Perspectives on Continuous Manufacturing||3rd PQRI/FDA Conference on Advancing Product Quality, Rockville, USA|
|Nov. 2016||PMDA Perspective on Continuous Manufacturing||13th Annual Meeting, DIA Japan 2016, Tokyo, Japan|
|Sep. 2016||Continuous Manufacturing
|2nd International Symposium on Continuous Manufacturing of Pharmaceuticals, Cambridge, USA|