过程确认培训.pptxVIP

Process Validation Approach Overview过程确认及方法概述;What is Process Validation (FDA)?什么是过程确认(FDA)？;What is Process Validation (GHTF)?什么是过程确认(GHTF)? ;Objective evidence is information that can be proved true, based on facts through observation, measurement, test or other means. 客观证据是可以通过观察、测量、测试或其他方法被证实为真实的信息。 ISO 8402 2.19 As the old saying goes, “If you didn’t document it, you didn’t do it!” 正如老话所说“如果你没有做记录，就等于你什么也没做”。 ;Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 通过检查并提供客观证据来证实已经满足特定的要求。 820.3 (aa) ;Process Validation Protocol过程确认方案;Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered. 用客观证据来支持证明，所安装的过程设备和辅助系统的关键安装方面，能满足制造商已批准的技术规范，且供应商的建议也被恰当的考虑了。 》2004 GHTF;Operational qualification (OQ) 操作鉴定（OQ）;Performance qualification (PQ) 性能鉴定（PQ）;Steps to Validation of a Process过程确认的步骤;过程确认的判定;Protocol development 方案编制 ;要求;过程确认小组;Installation Qualification (IQ)安装鉴定（IQ） ;Operational Qualification (OQ)操作鉴定（OQ）;Performance Qualification (PQ)性能鉴定（PQ）;When is Revalidation appropriate or required?什么时候要求再确认;Monitoring (FDA)监控（FDA）;文件输出;End Thanks! 结束 谢谢！