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Innovative Manufacturing Technology WG (IMT-WG)

Activities

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.

Established

July, 2016

Members

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

Document

PMDA Views on Applying Continuous Manufacturing to Pharmaceutical Products for Industry (provisional draft) (Mar. 30, 2018)

 

Past Presentations

Date Presentation Title Place
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
PMDA's Perspective
2nd International Symposium on Continuous Manufacturing of Pharmaceuticals, Cambridge, USA

 

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

Access/Map

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