FDA最新工艺验证指南(2011.1版)北大中英对译-已打印
GuidanceforIndustry ProcessValidation:General PrinciplesandPractices U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) CenterforBiologicsEvaluationandResearch(CBER) CenterforVeterinaryMedicine(CVM) January2011 CurrentGoodManufacturingPractices(CGMP) Revision1 本资料...
2011-fda行业指南_工艺验证(中英文对照):一般原则与规范GuidanceforIndustry行业指南ProcessValidation:GeneralPrinciplesandPractices工艺验证:(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1美国卫生与人类服务部食品药品管理局药物评价...
through commercial production which establishes scientific evidence that a process is capable of consistently delivering quality product.” The 2011 Guidance promotes a “lifecycle” approach to process validation that includes scientifically sound design practices, robust qualification, and process verification...
“lifecycle” approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. In particular, the 2011 Guidance describes process validation activities in three stages: • In Stage 1, process design, the commercial process is defined ...
2011-FDA行业指南_工艺验证(中英文对照):一般原则与规范.pdf,Guidance for Industry 行业指南 Process Validation: General Principles and Practices 工艺验证:一般原则与规范 U.S. Department of Health and Human Services Food and Drug Administration Center for Dr
Guidance for Industry 行业指南行业指南 Process Validation: General Principles and Practices 工艺验证:一般原则与规范工艺验证:一般原则与规范 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research...
Process Validation: General Principles and Practices Guidance for Industry1 工艺验证 一般原则与规范 2011/01 本指南代表了FDA目前对于此主题的看法。它不创造或赋予任何人任何权利,也并不束缚FDA或公众行为。可以使用满足适用的法令和法规的要求的替代性方法。如需讨论替代方法,请联系负责本指南实施的FDA工作人员。
2011-FDA行业指南_工艺验证(中英文对照)：一般原则与规范 Guidance for Industry 行业指南 Process Validation: General Principles and Practices 工艺验证：一般原则与规范 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)Center for ...