跟踪检查广西壮族自治区31家药品生产企业实施新版GMP后的缺陷情况分析

发布时间：2018-01-25 05:12

本文关键词： 新版《药品生产质量管理规范》缺陷跟踪检查质量管理体系　出处：《中国药房》2017年19期 　论文类型：期刊论文

【摘要】：目的:进一步提高药品生产企业对新版《药品生产质量管理规范》(GMP)的实施水平。方法:根据新版GMP标准及《药品生产现场检查风险评定指导原则》对广西辖区内11个地级市31家药品生产企业进行跟踪检查,分析药品生产企业实施新版GMP的缺陷及其原因并提出改进建议。结果与结论:31家药品生产企业中,通过新版GMP跟踪检查的有30家(96.8%);共发现缺陷331项,集中在设备、厂房与设施、质量控制与质量保证3个方面,分别为76、47、43项,占所有缺陷项目比分别为23.0%、14.2%、13.0%。缺陷出现的原因主要为机构与人员培训,厂房与设施、设备管理维护及定期校验不到位;物料与产品未制定有效期或复验期;相关确认与验证内容不全;质量控制、保证和质量管理、文件和生产管理不规范、不完善;自检方案过于简单等。建议药品监管部门建立健全法律法规体系,探索药品GMP跟踪检查新模式(如突击检查、细化检查等),加强检查员队伍培训力度,统一检查尺度;药品生产企业应严格按照新版GMP的要求进行生产,注重对重点知识的更新,加强培训的针对性,通过多方合力切实有效地保证药品质量。
[Abstract]:Objective: to further improve the quality management standard of drug production in drug manufacturing enterprises. Methods: according to the new version of GMP standard and the guiding principles of risk assessment for field inspection of drug production, 31 pharmaceutical manufacturing enterprises in 11 prefectural cities in Guangxi were followed up and inspected. This paper analyzes the defects and causes of the implementation of the new version of GMP in pharmaceutical manufacturing enterprises and puts forward some suggestions for improvement. Results and conclusions among 31 pharmaceutical manufacturing enterprises. Through the new version of GMP, there are 30 cases of 96.8%; A total of 331 defects were found, focusing on equipment, plant and facilities, quality control and quality assurance, respectively, 766 / 4743, accounting for 23.0% of all defect items. The main reasons for the defects are that the organization and personnel training, plant and facilities, management and maintenance of equipment and periodic check are not in place; Materials and products are not valid or re-inspection period; The contents of related confirmation and verification are incomplete; Quality control, assurance and quality management, documents and production management is not standardized, imperfect; The self-examination plan is too simple. It is suggested that the drug regulatory department establish and perfect the legal and regulatory system, explore the new mode of drug GMP tracking and inspection (such as surprise inspection, detailed inspection and so on), and strengthen the training of inspectors. Unified inspection scale; Pharmaceutical production enterprises should strictly follow the requirements of the new version of GMP, pay attention to the renewal of key knowledge, strengthen the pertinence of training, and ensure the quality of drugs effectively and effectively through joint efforts.
【作者单位】：广西壮族自治区食品药品审评查验中心;
【分类号】：R95
【正文快照】： *主管药师,硕士研究生。研究方向:食品药品审评查验。电话:0771-5886193。E-mail:lushihua2318@163.com[4]汪良兵,洪进,赵定涛,等.中国高技术产业创新系统协同度[J].系统工程,2014,32(3):1-7.[5]马澜.我国医药制造业创新能力的影响因素分析[J].科技管理研究,2012,32(16):10-13

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