良好的制药企业变更控制管理分析

Analysis of Good Change Control Management in a Pharmaceutical Manufacturer

目的促进制药企业更好地管理企业的变更,更顺利地开展变更控制管理。方法通过介绍制药企业常见的变更控制管理缺陷,分析导致这些缺陷的原因。结果与结论良好的制药企业变更控制管理流程,应当包括对变更的申请、评估、变更行动方案制订、变更申请的批准、执行变更行动计划、变更的批准和实施、变更实施后的跟踪。通过对变更控制管理流程的阐述,指导企业变更控制更规范,良好地进行变更控制管理。

Objective To promote the pharmaceutical manufacturer to manage the change of the manufacturer better,and to carry out the change control management more smoothly. Methods Through the introduction of the common change control management deficiencies in the pharmaceutical manufacturer,the reasons for these deficiencies were analyzed. Results and Conclusion A good change control management process in pharmaceutical manufacturer should include the change application, change evaluation, formulation of change action plan,approval of change application,implementation of change action plan,approval and implementation of change,and the review of the change implementation. Through the description of the change control management process, we can provide guidance for pharmaceutical manufacturer to carry out more standardized and better change control management.