药品生产中偏差的管理和控制

Deviation Management and Control in Pharmaceutical Production

关键词:  偏差  整改  质量管理

Key words:  deviation  corrective action  quality control关

摘要:

目的：对药品生产过程中出现的各种偏差进行有效的控制和管理, 以完善药品生产企业质量管理的软件系统中的偏差控制程序。方法: 根据cGMP的要求, 探讨偏差调查的范围、偏差调查报告的内容和后续的落实整改。 结论: 药品生产过程中出现偏差是很正常的, 只要对其认真彻底的调查,并且详细规范的记录, 科学有效的管理, 它最终体现的是药品企业份的质量管理水平，同时保证了用药的安全性。

Abstract:

Based on cGMP requirements, the scope of deviation investigation, the content of the report and investigation for deviation and the corrective action are discussed. For various deviations encountered in drug production, which is normal, effective control and management can be carried out so as to complement quality control software system in pharmaceutical enterprise. When deviation arises, it is necessary to investigate them thoroughly, to record them in detail and to manage them efficiently, then, the quality of the drug will be raised and the use of drug will be safe.