中国药业2025，Vol.34Issue(10)：34-39,6.DOI:10.3969/j.issn.1006-4931.2025.10.008
中药制剂共线生产风险评估和控制策略
Risk Assessment and Control Strategies in Collinear Production of Traditional Chinese Medicine Preparations
王丹 1宫文武2
作者信息
- 1. 云南省食品药品审核查验中心,云南 昆明 650106
- 2. 安徽省食品药品监督管理局,安徽 合肥 230051
- 折叠
摘要
Abstract
Objective To investigate a systematic risk assessment and control strategy in the collinear production of traditional Chinese medicine(TCM)preparations.Methods Based on the basic process of quality risk management and the corresponding analytical methods and guidelines in the International Council for Harmonisation(ICH)Q9,a basic model for risk assessment in the collinear production was established.Deficiency cases related to the collinear production of TCM preparations were evaluated,and corresponding control strategies were discussed.The risk assessment of inspection deficiencies was also conducted by using the Pharmaceutical Inspection Co-operation Scheme(PIC/S)and China's Good Manufacturing Practice(GMP)risk rating model,and focusing on collinear production of TCM preparations.Results and Conclusion The enterprise's collinear production risk assessment and control should at least include processes such as analysis of the characteristics of collinear produced varieties,formulation of control strategies,gap analysis and implementation of corrective actions,and follow-up verification of corrective strategies.It is recommended that drug inspectors(especially for TCM)focus on the implementation status of the above processes during collinear production inspections,and scientifically assess deficiencies based on their actual impacts.关键词
共线生产/风险评估/中药制剂/药品生产质量管理规范Key words
collinear production/risk assessment/traditional Chinese medicine preparations/good manufacturing practice for pharmaceutical products分类
医药卫生引用本文复制引用
王丹,宫文武..中药制剂共线生产风险评估和控制策略[J].中国药业,2025,34(10):34-39,6.
