Hiyama Yukio
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2010(128):1-16.
This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.
本报告描述了药品生产质量管理规范（GMP）在药品质量控制中的作用。药品质量控制有三个关键要素。它们是规格标准、研发过程中的全面产品特性描述以及遵守GMP，因为国际人用药品注册技术协调会（ICH）关于规格标准的Q6A指南在其背景部分提供了最重要的原则。讨论了2005年生效的修订版《药事法》（rPAL）对产品质量控制的影响。回顾了ICH关于药品研发（Q8）、质量风险管理（Q9）和药品质量体系（Q10）的讨论进展。为了在rPAL和ICH的新范式下重建监管机构的GMP指南和GMP检查体系，开展了一系列健康科学研究。对于GMP指南，编写了产品GMP指南、技术转移指南、实验室控制指南和变更控制系统指南。对于GMP检查体系，健康科学研究小组还提出了检查清单、检查备忘录和检查方案。由于药品及其原材料在国际上生产和分销，因此非常需要与其他国家当局开展合作。为了加强国际合作，在日本全国范围内统一建立GMP检查质量体系至关重要。
