2016—2019年被收回GMP证书的药品生产企业存在的缺陷分析及改进建议

Defective Items Analysis and Suggestions on Pharmaceutical Manufacturing Enterprises Withdrew Drug GMP Certificates in 2016-2019

关键词:  药品生产质量管理规范  收回药品GMP证书  药品生产企业  数据完整性

Key words:  GMP  withdrawal of GMP certificate  pharmaceutical production enterprises  data integrity

摘要:

目的 分析被收回药品生产质量管理规范（Good Manufacturing Practices，GMP）证书的药品生产企业存在缺陷的规律和特点，为药品生产企业更好地实施GMP，保证药品质量安全提供参考。方法 回顾和分析2016—2019年被收回GMP证书的中成药和化学药品制剂生产企业存在的缺陷及其逐年变化的趋势。结果 125家次收证企业累计缺陷项目频次为855次，涉及GMP正文及其附录17个章节。缺陷项目主要集中在数据可靠性存疑、擅自改变工艺规程、弄虚造假、物料管理混乱、偏差管理系统不能有效运行以及企业关键人员不能有效履职。2016—2018年，生产管理、设备、机构与人员以及厂房设施等章节缺陷项目的频次占比呈现逐年下降趋势，而质量控制与质量保证章节缺陷项目的频次占比大幅增加，确认与验证缺陷也存在上升趋势；除了计算机化系统涉及的数据可靠性问题和偏差处理方面的缺陷项目外，其他缺陷项目在收证企业中的频次占比都基本呈逐年下降趋势。结论 药品生产企业作为药品质量的责任主体，应将风险管理的理念贯穿在整个产品生命周期内，坚持诚实守信，不断加强数据完整性管理，注重对员工的针对性培训，提高全员质量意识，在产品风险评估的基础上建立质量管理体系并保证其有效实施和持续不断改进。

Abstract:

OBJECTIVE To provide reference for drug manufacturers to more effectively implement drug production quality management practices and ensure drug quality and safety by analyzing the rules and characteristics of the defects of the drug manufacturers whose GMP certificates have been withdrawn. METHODS The defects of Chinese patent medicine and chemical preparation drug manufacturers whose GMP certificates were withdrawn from 2016 to 2019 in China, and their trend of changes year by year were reviewed and analyzed. RESULTS The cumulative frequency of defect items of 125 companies was 855, involving 17 chapters of GMP text and its appendix. Defective items mainly focused on the six aspects of doubtful data reliability, unauthorized changes to process regulations, falsification, confusion in material management, ineffective operation of deviation management systems, and inability of key personnel to perform their duties effectively. From 2016 to 2018, the proportion of defective projects in production management, institutions and personnel, equipment and plant facilities showed a downward trend year by year, while in the quality control and quality assurance section, the proportion of defective items showed a significant increase trend, and the defects in the confirmation and verification chapter also showed an upward trend. Except for the data reliability issues involved in the computerized system and the defective items of deviation processing, the proportion of other defective items in the enterprises had basically shown a downward trend year by year. CONCLUSION Pharmaceutical manufacturers assume primary responsibility for drug quality. They should put the concept of risk management throughout the whole product life cycle, adhere to the principle of honesty and trustworthiness, constantly strengthen data integrity management, pay attention to targeted training of employees, improve the quality awareness of all staff, establish quality management system on the basis of product risk assessment and ensure its effective implementation and continuous improvement.