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.
(Activity period:：From July, 2016 to September, 2024)
(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.
Activities
Document
The activities conducted over the last five years.
Presentations
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
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