摘要
Abstract
Objective To provide guidance and suggestions for sterile drug manufacturing enterprises to continuously improve their quality management systems.Methods The one-time pass cases of inspection for conformity,the distribution of defect items and their risks based on the Good Manufacturing Practice of sterile drug manufacturing enterprises in Liaoning Province from January 2021 to June 2023 were summarized and analyzed,and the opinions and suggestions for improving the relevant quality system were proposed.Results A total of 129 enterprises participated in the inspection,and 127(98.45%)passed at one time.A total of 1 229 defective items were identified,including two severe defects(0.16%),48 major defects(3.91%),and 1 179 general defects(95.93%).The chapters with the most defects were the quality control,quality assurance,and document management.The risk points of serious defects were reflected in the authenticity of records,the performance of key personnel,etc;the risk points of main defects were reflected in the chapters of quality control,quality assurance,confirmation,verification,and document management.The general defects involved 166 items,of which 117 were found to involve multiple defects.Conclusion Enterprises should enhance personnel's sterile awareness,establish a risk thinking approach,improve document systematization,strengthen the rationality and traceability of records,strengthen facility and equipment management,control pollution at the source,enhance verification management,improve the concept of continuous process confirmation to further improve the quality management level of sterile drug production.关键词
无菌药品/药品生产质量管理规范/风险Key words
sterile drug/Good Manufacturing Practice/risk分类
药学
