Top News The 48th GMP Case Study Workshop in 2021" held
As part of its business activities in fiscal 2021, the Quality Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) held the "FY2021 (48th) GMP Case Study Workshop" on September 10, 2021, under the theme of "Enforcement of Revised GMP Ordinance and Quality Assurance in the Coronavirus Disaster" in cooperation with the Japan Pharmaceutical Information Center (JAPIC). From the viewpoint of preventing the spread of new coronavirus infection, this year, as in 2020, the conference was held in an online seminar format instead of being held at the venue. The seminar was a success with approximately 800 participants.
Moderator of the online seminar (Conference Room 2, Pharmaceutical Cooperative Association of Japan)
In the wake of the new coronavirus infection, I believe that it has been a year of searching for new ways to conduct GMP (Good Manufacturing Practice) activities that differ from conventional methods, such as remote auditing and the introduction of telework. Although the new coronavirus infection has not yet ended, there is a possibility that a shift from the conventional way of thinking will be promoted for GMP operations after the virus has ended.
Meanwhile, following the "Law for Partial Revision of the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Related Matters" promulgated in 2019 (effective August 1, 2021), a revised GMP Ministerial Ordinance was promulgated in April this year, and a pharmaceutical quality system (ICH Q10) based on internationally harmonized GMP standards The revised ministerial ordinance clearly stipulates the introduction of a pharmaceutical quality system (ICH Q10) based on internationally harmonized GMP standards, provisions for equipment sharing, assurance of data integrity, etc., and we expect that all companies are working toward implementation.
In FY2021, Ms. Emiko Hirayama of the Pharmaceutical Quality Control Department of the Pharmaceuticals and Medical Devices Agency (PMDA) gave a special lecture titled "Explanation of the Operation of the Revised GMP Ministerial Ordinance and the New System Established by the Revised Pharmaceutical Affairs Law," explaining PMDA's efforts in the Corona Disaster and the new classification conformity stipulated in the revised GMP Ministerial Ordinance and revised Pharmaceutical Affairs Law. The presentation included PMDA's expectations and explanations of the Post-Approval Change Management Protocol (PACMP) system and new standards for GMP conformity assessment, which were newly stipulated in the revised GMP Ordinance and the revised Pharmaceutical Affairs Law. In the case study presentations, three presentations were made by member companies of the Pharmaceutical Manufacturers Association of Japan (PMDA) on the theme of this year's conference, such as the introduction of computerization at manufacturing sites and remote audits. Each presentation provided detailed explanations of each company's experiences and innovations, and participants asked more than 50 questions online, with the most representative questions being answered 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 in the future.
Introduction of each presentation
Special Lecture
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1.Explanation of the operation of the revised GMP Ministerial Ordinance and the new system established by the revision of the Pharmaceutical Affairs Law
Ms. Emiko Hirayama, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA)
Presentation of case studies
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2.The computerization initiative at the Shizuoka Plant of Kaken Pharmaceutical Co.
Takuya Fujisawa, Quality Control Office, Kaken Pharmaceuticals
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3.A case study of remote auditing at Dainippon Sumitomo Pharma Co.
Koji Koyama, Dainippon Sumitomo Pharma, Drug Assurance Department
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4.Example of inspection of a medical institution regarding raw material cells (autologous cells) for regenerative medical products
Mr. Tatsuhiro Mori, Global Pharmaceutical Development Division, Novartis Pharma
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5.The computerization initiative at the Shizuoka Plant of Kaken Pharmaceutical Co.
Takuya Fujisawa, Quality Control Office, Kaken Pharmaceuticals
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.
( Akihiro Sugimura, GMP Case Study Workshop Project, Quality Committee)