Deviation Management 偏差管理.pdfVIP

Pharmaceutical Services Corporation 美国医 服务有限公司 Deviation Management 偏差管理 PDF 文件使用 pdfFactory Pro 试用版本创建 Definition 定义 Departure from an approved instruction or established standard - ICH 与批准的指令或制定的标准产生的偏离- ICH PDF 文件使用 pdfFactory Pro 试用版本创建 2 Background 背景 Production record review is one of the most frequent GMP deviations observed 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, observations regarding this subject were No. 1 in the ranking of cited GMP deficiencies 在财政2005 、2007和2008年，关于此方面列举的GMP缺陷 排名第一 Most observations are caused by failures in deviation management and CAPA 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 PDF 文件使用 pdfFactory Pro 试用版本创建 3 Background 背景 In most cases, deviations were noticed by the pharmaceutical company but no sound investigation was performed and no consequences were defined 大多数情况，制 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。 PDF 文件使用 pdfFactory Pro 试用版本创建 4 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 应尽量避 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