Top News The "FY2020 (47th) GMP Case Study Workshop
As part of its FY2020 business activities, the JPMA Quality & Technology Committee held the "FY2020 (47th) GMP Case Study Workshop" on September 11, 2020 under the theme of "Revised GMP Ordinance and Future Quality Assurance" in cooperation with the Japan Pharmaceutical Information Center, Inc. The seminar was held in an online seminar format instead of at the venue this year from the viewpoint of preventing the spread of the new coronavirus. 1600 participants attended the successful event.
Scene of the online seminar venue (JPMA Conference Room 2)
As a major topic related to pharmaceutical manufacturing and sales in fiscal 2019, the "Act on Partial Revision of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Related Matters" was promulgated on December 4, 2019. Many items that directly affect Good Manufacturing Practice (GMP) are included in this law, such as "review of GMP/GCTP surveys for international harmonization," "computerization of accompanying documents," and "mandatory bar code labeling on packaging, etc.". In addition, the scheduled enforcement period is clearly indicated for each of the revised items, and systematic operational responses are required accordingly.
In addition, a revised GMP Ministerial Ordinance is expected to be promulgated in FY2020, and proposed revisions have already been announced, including the introduction of a pharmaceutical quality system (ICH Q10) based on internationally harmonized GMP standards, quality risk management (ICH Q9), provisions for equipment sharing, and ensuring data integrity (DI). The companies are also required to support the GMP system. It is expected that each company will be progressively inspecting its GMP system for response and compliance.
This time, Mr. Tsuneki Akazawa of the Pharmaceutical Quality Control Department of the Pharmaceuticals and Medical Devices Agency (PMDA) gave a special lecture titled "Recent Guidance Cases and Regulatory Trends," focusing on problems occurring at manufacturing sites, the mechanisms and fundamental solutions to fraud, and the international situation and issues surrounding GMP at the PMDA. The presentation included expectations, the purpose of the proposed revision of the GMP ordinance, and Explanation. In the case study presentations, JPMA member companies cooperated to present a total of four case studies related to this year's theme, including their responses to the revised GMP ordinance and data integrity initiatives. Each presentation provided detailed explanations of each company's experiences and innovations. 114 questions were submitted online by participants, and answers were provided after the presentations.
We hope that the special lectures and case study presentations were very meaningful for improving the quality assurance level of each company and will serve as a useful reference for future reference.
Special Lecture
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(1)Recent Guidance Cases and Regulatory Trends
Dr. Tsuneki Akazawa, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Case Study Presentations
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(2)Status of Daiichi Sankyo Group's Response to the Revised GMP Ordinance
Mr. Haruhiro Takenoshita, Daiichi Sankyo Espha Reliability Assurance Department
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(3)Data Integrity (DI) Initiatives at Takeda Pharmaceutical Company Limited
Dai Yamashita, Quality Assurance Department, Takeda Pharmaceutical Company Limited
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(4)JPMA GMP Subcommittee's Efforts Related to Quality Culture
JPMA Quality & Technology Committee, GMP Subcommittee, Quality Culture Project
Mr. Hiroshi Fujie, Chugai Pharmaceutical Co. -
(5)Explanation of BioWeber Guidelines based on Biopharmaceutics Classification System (BCS) and Issues in Japan
JPMA Quality & Technology Committee, ICH Quality Group
Yutaka Takahashi, Astellas Pharma Inc.
Summary
The JPMA Quality & Technology Committee, in accordance with its business activity policy, is committed to contributing to the further development of the JPMA industry by providing more practical topics in addition to actively disseminating information through the GMP Case Study Workshop, GMP Roundtable Meeting, Pharmaceutical Quality Forum, etc., and will continue to support the internationalization and upgrading of quality assurance systems in cooperation with the government and other organizations. We will continue to support the internationalization and upgrading of quality assurance systems in cooperation with the government and other organizations.
( Tadashi Okabe, Quality & Technology Committee, GMP Case Study Group Project)