The Guidance provides a set of inspection guidelines for contract manufacturing organizations (CMOs) that engage in outsourced manufacturing activities on behalf of MAHs. The guidelines cover various key aspects, including personnel and internal organizational structure, alignment of quality management systems (QMS) between the MAH and the CMO, testing requirements, pharmacovigilance requirements, and more.
- Local Title:国家药监局综合司关于印发药品上市许可持有人委托生产现场检查指南的通知
- Country/Region:Chinese Mainland
- Competent Authority: National Medical Products Administration (NMPA)
- Status:In force
- Release Date:2023-10-24
- Implementation Date:2023-10-24