Quality Committee
Priority Issues and Activities
1. GMP Subcommittee
1) New project initiatives
In response to the recent changes in the environment surrounding GMP, the project will plan and manage activities to address quality assurance of new pharmaceutical products based on innovation, as well as further progress in the field of ICH quality and the restoration of trust in quality. In the future, as part of efforts in new technological areas, the promotion of commercial production digital transformation (DX) as an application of digital, data, and technology, including machine learning and AI, to the field of quality management will be discussed.
2）Asia collaboration response to the Asian Pharmaceutical Association Collaboration Conference (APAC), etc.
As part of activities in response to Asian collaboration, in addition to further fostering inspection techniques (human resource development) of inspectors in Asia and other countries, discuss quality issues in APAC to provide new drugs to Asian countries more quickly, and strengthen collaboration with related countries.
3) Understanding regulatory trends related to GMP overseas and communicating them to member companies through activities such as overseas Guidance Watchers and translation of GMP guidelines.
In addition, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), National Medicines Protection Agency (NMPA) of China, Korea Food and Drug Administration (MFDS), Food and Drug Administration (TFDA) of Taiwan, Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Swissmedic, Australian Pharmaceuticals Agency (Swissmedic), and the Australian Food and Drug Administration (ADFA). The committee also collects and distributes information to be disseminated to member companies without delay, including the latest information from the Pharmaceutical Manufacturers Association of Japan (PMAJ) International Committee and individual information from each company. In cooperation with the International Committee's Asia Subcommittee, the committee also conducts surveys and public comments on GMP regulations in China, ASEAN countries, etc., and provides useful information to member companies engaged in export and change control. Translate, as necessary, revised GMP/GDP documents of the European Union (EU), the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S), and the FDA, which are undergoing significant revision, and disseminate them using GMP News and other media, as well as share the status of each company's initiatives in response to the regulations introduced in the project. ICH Quality
(4) Support for ICH GMP-related issues
The ICH Support Project, which was newly launched last year to support the activities of the ICH quality area, will continue to study the Q9(R1) guidelines, translate training materials, and provide quality support for ICH project-related activities in order to establish the guidelines in Japan. Support ICH project-related activities from a quality perspective and ensure that the guidelines are firmly established in Japan.
5）Continuous Production Project
Collect information on quality issues in continuous production, including overseas and domestic approval information, information on PAT monitoring technology, etc., and study solutions to issues related to the introduction of continuous production.
6）Quality Culture Project
In order to properly implement GMP and produce quality products, it is necessary not only to comply with related laws and regulations, but also to foster a "quality culture" that considers what to do and acts accordingly, and we have been continuously presenting the results of our studies at academic conferences. On the other hand, given the current situation where quality problem cases continue to occur, we will start a project to build a good relationship of trust between pharmaceutical companies and contract manufacturing organizations in order to further consider this as one of the solutions.
7）Responding to issues related to the Pharmaceuticals and Medical Devices Act and making proposals in cooperation with the Japan Pharmaceutical Manufacturers Association
To work closely with the Quality Committee of JFYR and participate in JFYR's project. Participate in projects such as studies to prevent recurrence of quality problem cases, to respond to the Pharmaceutical Affairs Law and GMP Ministerial Ordinance after its revision and quality-related notifications, to respond to nitrosamine WT, and to revise PIC/S GMP-related notifications, etc., to ensure further reliability of pharmaceutical quality and to enhance GMP as a foundation for globalization. In this fiscal year, we will submit requests and take other actions in industry discussions for the next revision of the Pharmaceutical Affairs Act.
2. Formulation Research Subcommittee
(1) Project Activities
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Project for utilization and implementation of digital tools in the field of pharmaceutical formulation
The project aims to improve the quality and development capability (efficiency and speed) of pharmaceutical products through the effective use and implementation of digital tools. This year, for the two sub-themes ((1) Study on promotion of lab automation and automation, and (2) Study on implementation of DX in the pharmaceutical manufacturing industry), a questionnaire will be conducted to collect information on precedents, industry needs, and obstacles to introducing DX tools, and the results of the analysis will be presented in papers, conferences, etc. After that, the possibility of practical application of each of these products will be examined.
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Lipid Nanoparticle (LNP) Formulation Development Promotion Project
With the aim of accelerating the development of LNP products from Japan and enhancing their competitiveness overseas, we will conduct mock quality consultations on mRNA-LNP formulations for the following case studies. This year, we will continue to collect information for the implementation of the consultation and complete the research report for Case Study B.
Case Study A: Comparability protocol for manufacturing process change of passive targeting LNP formulation.
Case Study B: Quality requirements for initiation of clinical trials for active targeting LNP formulations with Fab ligands -
Project to study the description of Established Condition (EC)/Manufacturing Method
Based on the domestic implementation of ICH Q12 and the current issues of manufacturing method description from the viewpoint of CMC development and manufacturing, we will review and propose how the manufacturing method description (including change classification for the description) should be from a technical viewpoint. This year, we will prepare a technical white paper summarizing past case studies on the manufacturing of chemical product formulations, and make policy recommendations through the activities of the AMED Chemical Product Subcommittee in cooperation with the Pharmaceutical Affairs Committee.
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Outsourced Problem Solving Project
The purpose is to avoid problems during the outsourcing of drug product manufacturing in the latter stages of development, and to resolve issues mainly by examining them from a technological perspective. Based on examples from the selection of contractors to shipment of investigational drugs extracted from each company's experience, a checklist of items to be checked at each stage will be prepared this fiscal year. In addition, a questionnaire, etc. will be conducted through the Japan CMO Association in order to produce deliverables that incorporate the perspective of the contractor side.
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Bioequivalence Project
By studying the impact of the issuance of ICH M13 on the current GLs and implementing ICH M13 in Japan, we will reduce the burden of BE studies in new drug development and contribute to speeding up drug development in Japan. In this fiscal year, we will continue to discuss the revision of the current GL for the implementation of M13A in Japan, and analyze the gap between the Japanese, U.S., and European guidelines and make recommendations for M13B, which is currently under consideration, and M13C, which is scheduled to be implemented in the future.
3. ICH Quality Group
1) Ongoing discussion and response to active topics
Continue discussions on ICH Q1/Q5 (stability studies) and M4Q (R2) (CTD - Guideline on Procedures for Preparation of Quality Documentation), which are active ICH Q1/Q5 and M4Q (R2) are scheduled to reach Step 1 in early 2025 ICH Q3E (Extracted and dissolved substances of pharmaceutical products) is continuing scientific discussions with external experts, with the aim of reaching Step 1 in the first half of 2025.
2) Issuance of opinions by the Pharmaceutical Manufacturers Association on new topics
ICH Q6 (R1) (Standards and Test Methods) EWG activities will be supported by a new round of discussions starting in 2024.
Both of the topics under discussion are not only within the ICH project, but will be revisions of guidelines that will have a significant bearing on future applications, so we will provide support while collaborating with related committees and gathering opinions from members of other topics.
We will also actively register support staff to identify and develop human resources related to quality issues in the pharmaceutical industry. In parallel, new topics will be discussed in collaboration with those who have worked with the working group in the past, and proposals will be made and evaluated as they are proposed.
3) Preparation of ICH training materials
We will continue to create and translate training materials for Q13, Q2/Q14, Q5A, and Q9 (R1), which reached Step 4, and actively engage in activities to establish these materials in Japan.