摘要
目的:探讨药品生产企业质量管理中存在的问题,并提出相应的对策。方法:采用问卷调查的方式,对某市7家药品生产企业的基本情况、人员资质、检验仪器设备、质量控制等方面进行调查,并对相关数据进行统计汇总,分析其存在的问题。结果与结论:所调查的7家企业共有36条生产线、263个药品批准文号、1 268名职工。7家企业中,质量管理人员大专以上学历者占61.9%,质量检验人员大专以上学历者占36.4%;质量管理和检验人员工龄结构较合理,10年以下和10年以上各占50%左右。部分企业检验仪器设备不能满足现实要求,需要委托检验。各企业基本能按《药品生产质量管理规范》的要求对纯化水、注射用水系统及洁净室的洁净度定期进行监测。但各企业发展不均衡,人员素质有待提高,检验能力参差不齐,监管机制和法规体系不完善。建议企业应强化培训,不断提高质量管理和检验人员专业水平,并及时购置相关检验仪器设备;政府相关部门应完善监管机制,健全法规体系,强化技术监督,提高监管水平,确保药品质量。
OBJECTIVE： To discuss the problems of quality management in pharmaceutical manufacturers and put forward the corresponding countermeasures. METHODS： By questionnaire survey, 7 pharmaceutical manufacturers were investigated in terms of basic situation, personnel qualification, test equipment, quality control, etc. The relevant data were summarized statistically to analyze its problems. RESULTS ＆ CONCLUSIONS： 7 included enterprises own 36 production lines, 263 drug approval number and 1 268 employees in total. There were 61.9% of quality management staffs with college degree or above and 36.4% of quality inspection staffs with college degree. Quality management and inspection personnel are more reasonable in structure of length of ser- vice, less than 10 years and more than 10 years of length of service accounted for 50%, respectively. Inspection equipment can not meet the practical requirements in part of enterprises, and quality inspection should be entrusted to other companies. Each enterprise can regularly monitor purified water, water for injection system and clean class of clean room according to the requirements of GMR But there still are some problems, such as unbalanced development, low quality of personnel, uneven inspection ability and not perfect regulations and supervision system. It is suggested to strengthen the training, constantly improve the quality manage- ment and the skill of inspection personnel and timely purchase related inspection equipment. Relevant government departments should improve the regulatory mechanism, perfect laws and regulations system, strengthen supervision and improve the supervision level to ensure the quality of drugs.
出处
《中国药房》
CAS
CSCD
2014年第17期1561-1564,共4页
China Pharmacy
关键词
药品生产企业
质量管理
质量检验
Pharmaceutical manufacturers
Quality management
Quality inspection
