Pharmaceutical Services Corporation 美国医药服务有限公司Deviation Management
草地上来了一只羊偏差管理
Definition
定义
•Departure from an approved instruction or established standard-ICH
向日葵画法与批准的指令或制定的标准产生的偏离-ICH
•Production record review is one of the most frequent GMP deviations obrved by the FDA
生产记录审核是FDA发现GMP偏差频次最高的之一
•In the fiscal years 2008, 2007 and 2005, obrvations regarding this subject were No. 1 in the ranking
隐形眼镜
of cited GMP deficiencies
松仁玉米的家常做法在财政2005、2007和2008年，关于此方面列举的GMP缺陷排名第一
风景秀丽
•Most obrvations are caud by failures in deviation management and CAPA
橘皮的功效与作用发现的大多数问题是因为没有进行偏差管理和采取纠正预防行动
•In most cas, deviations were noticed by the pharmaceutical company but no sound investigation was performed and no conquences were defined
大多数情况，制药企业注意到了偏差，但没有进行彻底地调查，也没有做出结论。
Regulation Requirement
法规要求
•Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occurs, it should be approved in writing by a competent person, with the involvement of quality control department when appropriate
标准网球场尺寸>下腰痛应尽量避免偏离指示或规程。如果发生偏差，应由授权人书面批准。当必要时，还需质量控制部门的介入。
•Any deviations from established procedures should be documented and explained. Critical deviations should be investigated and its conclusions should be documented.
对任何偏离于已制定的规程的偏差都应进行记录和解释。应对重要偏差进行调查，并记录所得出的结论。
