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本课题着眼于制剂生产企业清洁和清洁验证现状及原因对策分析,通过国内外文献检索研究,比较欧盟、美国、WHO在清洁及清洁验证相关法规方面的要求;通过利用危害分析关键控制点(HACCP)风险管理分析工具对共线生产制剂设备清洁及清洁验证的风险因素进行分析并进行等级划分,针对关键的和主要的风险因素,以上海市药品生产企业为调查研究对象,对嘉定区、闵行区共计31家制剂生产企业进行走访、座谈、发放调查问卷,从生产企业的基本情况、清洁现状、人员组织情况、清洁验证组织情况、方法和实施情况进行分析,指出存在的问题,进而提出相应监管对策和建议,探索药品生产企业清洁验证风险控制监管模式。
This topic focuses on the status quo and countermeasures of cleaning and cleaning validation of preparation enterprises, and compares the requirements of the EU, the United States and WHO on the relevant regulations on cleanliness and cleanliness verification through literature search and research at home and abroad. By using the key points of control of hazard analysis (HACCP ) Risk Management Analysis Tools The risk factors for cleaning and cleaning verification of collinear production equipment were analyzed and ranked. According to the key and major risk factors, the drug manufacturing enterprises in Shanghai were investigated. District, a total of 31 manufacturing enterprises to visit, discussion, the issuance of the questionnaire, from the basic situation of the production enterprises, the status of the cleaning, personnel organization, organization of cleaning verification, methods and implementation analysis, pointed out the existing problems, and then put forward the corresponding Regulatory measures and recommendations to explore drug manufacturing enterprises clean validation risk control regulatory model.