关键词: 上市后变更, 变更控制, 检查缺陷, 药品生产, 药品生产质量管理

Abstract:

Change control， as a core component of the pharmaceutical quality management system （QMS）， is integral throughout the drug lifecycle， playing a critical role in ensuring drug quality， safety， and efficacy. In the rapidly evolving pharmaceutical industry， it serves as a vital mechanism to ensure that quality improvements do not adversely affect product quality， requiring manufacturers to rigorously monitor， evaluate， and investigate even minor changes to production processes， conditions， or the QMS itself. This study addresses current challenges in pharmaceutical change control by analyzing domestic and international regulatory guidelines and policies， supported by practical case studies， to examine contemporary practices from a comprehensive QMS perspective. It systematically identifies deficiencies in change control systems observed during recent inspections， highlighting common issues in documentation frameworks， risk assessment accuracy， change classification， implementation strategies， operational effectiveness， follow-up monitoring， and regulatory compliance. The study synthesizes key implementation considerations and provides improvement recommendations， offering valuable insights for Chinese pharmaceutical enterprises to enhance their change control systems and for regulators to optimize inspection efficiency.

Key words: Post-marketing change； , Change control； , Deficiencies； , Medicine production； , Good manufacturing practice of medical products