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Regulatory Science/The Science Board/Standard Development

Innovative Manufacturing Technology WG (IMT-WG)

Activities

As QbD (Quality by Design(Note))-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.

(Note) 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 to V (Quality)
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Manufacturing Quality for Drugs
Office of Review Management
Office of Regulatory Science Coordination

Document

 

Past Presentations(Last 5 years)

The 4th Symposium of the International Consortium for Advanced Medicines Manufacturing, Cambridge, USA , April 2023

 

NIFDS-DIA Conference 2022,  Seoul, Korea, November 2022

 

DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop, Mumbai, India (Web), September 2022

 

NMPA Training on Continuous Manufacturing, Beijing, China(Web), August 2022

 

Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals”, Tokyo (Web), June 2021

 

ISPE Singapore Affiliate Conference and Exhibition 2020, Singapore (Web), December 2020

 

The 4th FDA/PQRI Conference on Advancing Products Quality, Rockville, USA, April 2019

 

CMC Strategy Forum Japan 2018, Tokyo, December 2018

 

15th DIA Japan Annual Meeting 2018, Tokyo, November 2018

 

3rd International Symposium on Continuous Manufacturing of Pharmaceuticals, London, UK, October 2018

 

2018 ISPE Continuous Manufacturing Workshop, Arlington, USA, June 2018

 

2018 Annual Meeting ISPE Japan Affiliate, Tokyo, Japan, May 2018

 

Publications

2021
  • Control strategy and methods for continuous direct compression processes

Asian J Pharm Sci. 16 (2):253-262, 2021

 
  • Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

Chem Pharm Bull. 69 (2):211-217, 2021