Top News Held the 47th GMP Case Study Workshop in FY2020
As part of its FY2020 business activities, the Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality 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 in order to prevent the spread of the new coronavirus.
Online seminar venue (Pharmaceutical Cooperative Society of Japan Meeting Room 2)
On December 4, 2019, the "Act for Partial Revision of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices" was promulgated as a major topic related to pharmaceutical manufacturing and sales in FY2019. 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 to the introduction of a pharmaceutical quality system (ICH Q10) based on internationally harmonized GMP standards, the introduction of quality risk management (ICH Q9), provisions regarding the sharing of equipment, and ensuring data integrity (DI), etc. have already been announced. 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 an introduction of the expectations and the purpose of the proposed revision of the GMP ordinance, as well as explanations. In the case study presentations, four presentations were made by member companies of the Pharmaceutical Manufacturers Association of Japan (PMDA) on their responses to the revised GMP ordinance, data integrity initiatives, and other topics related to the theme of this year's conference. 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 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)Efforts related to Quality Culture in the GMP Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Quality Culture Project, GMP Subcommittee, Quality Committee, Pharmaceutical Manufacturers Association of Japan
Mr. Hiroshi Fujie, Chugai Pharmaceutical Co. -
(5)Explanation of BioWeber Guidelines based on Biopharmaceutics Classification System (BCS) and Issues in Japan
ICH Quality Group, Quality Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
Yutaka Takahashi, Astellas Pharma Inc.
Summary
In accordance with its business activity policy, the Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality Committee intends to contribute to the further development of the pharmaceutical 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 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, GMP Case Study Group Project, Quality Committee)