唐文燕+颛孙燕+李建平

摘 要 本文通过对近期药品委托生产的检查情况及变更情况进行汇总，结合企业调研情况及国外委托生产和变更控制的监管机制分析，探讨我国药品委托生产中变更管理的策略，以此提高药品委托生产现场检查的检查效率，为保证检查质量和药品质量安全提供技术支持，也为药品生产企业提供有效的技术指导。药品委托生产是产业发展的必然趋势，但当前的委托生产仍然存在一些问题，发生变更是一个常见现象，监管部门应从技术监管方面加以严格管理，不断完善相关法规政策，解决实施过程中出现的问题，以便更好的规范药品委托生产，确保药品质量安全。

关键词 药品委托生产 变更 评价分析 策略

中图分类号：R951 文献标识码：C 文章编号：1006-1533（2017）17-0042-04

Change analysis and management strategy in contract manufacturing of drugs

TANG Wenyan*， ZHUANSUN Yan， LI Jianping**

（Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China）

ABSTRACT Strategies for change management in contract manufacturing of drugs in China were discussed based on the recent inspection of contract production of drugs and the change summary analysis combined with the supervision mechanism of domestic and foreign enterprises in contract production of drugs so as to improve the inspection efficiency of the commissioned production site inspection and provide technical support for ensuring the quality of inspection and drug quality and safety and also effective technical guidance for the pharmaceutical production enterprises. Contract production of drugs is the inevitable trend of industrial development， however， there still exist some problems in it. So the change is a common phenomenon， strict management should be implemented from technical supervision by government regulators， and the relevant regulations and policies should be constantly improved to solve the problems happened in the implementation process so as to better regulate the contract production of drugs and to ensure drug quality and safety.

KEy WORDS contract manufacturing of drugs； change； evaluation and analysis； strategy

藥品委托生产是指药品生产企业在因技术改造暂不具备生产条件和能力或产能不足不能保障市场供应的情况下，将其持有药品批准文号的药品委托其他药品生产企业全部生产的行为。委托方和受托方均是持有与委托生产药品相适应的GMP证书的药品生产企业。药品委托生产因其能够有效整合社会资源、降低生产成本、盘活现有资源等优势被越来越多的药品生产企业采用。

但是，在我国药品委托生产起步较晚，在1999年10月8日国家局发布的《关于药品异地生产和委托加工有关规定的通知》中才首次明确管理[1]。虽然之后陆续出台了药品委托生产相关的管理规定，但大都是对审批环节的行政要求规定，而相应的技术要求较少。……