浅谈药品生产企业在药品生产过程中的偏差管理

Discussion On the Management of Deviations in the Process of the Pharmaceutical Production by the Pharmaceutical Manufacturers

目的阐述偏差的概念。方法药品生产企业质量管理部门应按照《药品GMP认证检查评定标准》的规定,制定和执行偏差处理程序,所有偏差应有记录,重大偏差应有调查报告。结果与结论提出我国药品生产企业在药品生产过程中出现偏差应如何进行处理的一些建议。

Objective To expatiate on the concept of deviation. Methods The department of quality management of the pharmaceutical manufacturers should be in accordance with the ＂ Assessment Standards of GMP Certification Inspection＂, should develop and implement the procedures to deal with bias. All of errors should have been recorded, and the material deviation＂ should have an investigation report. Results and Conclutions To put forward some of the recommendations how Chinese pharmaceutical manufacturers should deal with the deviation in the process of the pharmaceutical production.