QBA, San Carlos, CA
Quality Systems and Quality Management, Global Quality and Compliance, Genentech/Roche, South San Francisco, CA.
PDA J Pharm Sci Technol. 2021 Sep-Oct;75(5):454-457. doi: 10.5731/pdajpst.2021.012627. Epub 2021 Mar 15.
Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug product. Because many PACs require prior approval by individual regulatory agencies each having their own reporting requirements and approval timelines, this results in companies having to manage several versions of a manufacturing process at the same time. The global regulatory complexity increases risk of drug shortages. Chief quality officers and heads of quality from more than 20 global pharmaceutical companies have come together to speak with One-Voice-of-Quality (1VQ) and develop solutions to this problem by developing a science and risk-based approach to manage more PACs in the pharmaceutical quality system (PQS) rather than submitting these as prior approval supplements. Pharmaceutical companies already conduct management review (MR) according to the International Conference on Harmonization (ICH) Q10. This One-Voice-Of-Quality paper is a practical guide on how companies can expand the MR to also evaluate and demonstrate the effectiveness of their PQS in specifically managing PACs to achieve regulatory flexibility as stated in ICH Q10, Annex 1. Examples of PQS key performance indicators (KPIs) that may be used to assess, plan, implement, and monitor PACs are described. The intent is to provide assurance through MR that PACs can be managed effectively in the PQS, thereby resulting in a reduced need for regulatory prior approval of certain low risk changes that enhance product availability, reduce the risk of drug shortages, and/or facilitate timely innovation and continual improvement in the pharmaceutical industry. This document is endorsed by 1VQ chief quality officers and heads of quality.
药品获批后变更（Post-approval changes，PACs）在药品整个生命周期内不可避免且有其必要性。由于许多 PACs 需要经过各个监管机构的事先批准，而每个机构都有自己的报告要求和审批时间，这导致公司同时需要管理多个版本的生产工艺。全球监管的复杂性增加了药品短缺的风险。来自 20 多家全球制药公司的首席质量官和质量负责人齐聚一堂，与 One-Voice-of-Quality（1VQ）进行了交流，并通过制定一种基于科学和风险的方法来解决这一问题，即在制药质量体系（Pharmaceutical Quality System，PQS）中管理更多的 PACs，而不是将这些变更作为事先批准补充提交。制药公司已经根据国际人用药品注册技术协调会（International Conference on Harmonization，ICH）Q10 开展管理评审（Management Review，MR）。本文是 1VQ 质量负责人的实用指南，介绍了公司如何将管理评审扩展到评估和证明其 PQS 专门管理 PACs 的有效性，以实现 ICH Q10 附录 1 中规定的监管灵活性。文中还描述了可用于评估、规划、实施和监测 PACs 的 PQS 关键绩效指标（Key Performance Indicator，KPI）的示例。其目的是通过管理评审提供保证，即 PACs 可以在 PQS 中得到有效管理，从而减少对某些低风险变更的监管事先批准的需求，这些变更可以提高产品的可获得性、降低药品短缺的风险，和/或促进制药行业的及时创新和持续改进。本文得到了 1VQ 首席质量官和质量负责人的认可。
