and validation programme. This should form part of the Validation Master Plan. However, the Quality Assurance function of a company should normally have a critical role in overseeing the whole qualification and validation process. It is recommended that the validation programme be actively co-ordinate...
Ø Validation Master Plan Ø Installation and Operational Qualification Ø Non-Sterile Process Validation Ø Cleaning Validation The four Recommendations comprising this document define general principles pertaining to each of the topics. 2.1 Purpose of the document ...
recommendation-on-validation-master-plan (质量风险管理参考资料).pdf,PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 006-3 25 September 2007 RECOMMENDATIONS ON VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALI
PAGE Pag. 4848VALIDATION MASTER PLAN验证主计划 China Co., Ltd.MANUFACTURING PLANT有限公司工厂PREPARED BY:制定人:QA MANAGERQA经理CHECKED
内容提示: VALIDATION MASTER PLAN验证主计划PREPARED BY: ...制定人: QA MANAGER /QA 经理CHECKED BY: ...审核人: HEAD OF QA/质量经理APPROVED BY: ...批准人:Guang dong Intmed MedicalAppliance CO.,Ltd广东因特圣医疗器械有限公司VERSION/版本:VALID DATE/生效日期 文档格式:PDF...
Validation master plan 验证主计划 8 Qualification and validation protocols 确认和验证方案 9 Qualification and validation reports 确认和验证报告 10 Qualification stages 确认程序 11 Change control 变更控制 12 Personnel 人员 References 参考文献 Appendix 1 附录1 Validation of heating, ventilation and...
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这一方面的内容很多,比如IPSE中关于计算机系统验证都有几个报告,内容很多,目前国内就只关注GAMP5,其实ISPE还有专门关于实验室计算机验证的报告等待好多的,而中英文版本还是比较罕见的资料计算机系统验证主计划(中英文对照).pdf
Computerized laboratory Data Acquisition Systems 技术报告31期 计算机实验室数据 采集系统的验证和确认 PDA Journal of Pharmaceutical Science and Technology 制药科学于技术PDA杂志 1999 Supplement 增刊 Volume 53 第53册 Number 4 第4期
Validation Master Plan: The Validation Master Plan is a direct result of the inventory system assessment. It is a document that lists and prioritizes the computer systems/applications to be validated and associated responsibilities and timelines. In the list there may be systems that are ...