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。
19 i Guidance for Industry1 Process Validation: General Principles and Practices This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public...
生产过程中未记录的变更也受到批评。 As a result, the FDA expects well defined process parameters andraw material properties for the manufacturing process of creams and ointments.The FDA expects the process validation to result in an assessment of theprocess reliability and controllability with regard t...
当前API的cGMP规范包括进行科学合理的原材料测试(raw material testing)、工艺过程监控(in-process control)、放行(release)和稳定性测试(stability testing)、工艺验证(process validation)以及对从此类测试中产生的任何OOS结果进行充分调查。合同测试实验室(contracting laboratory)对于上述责任的担当要求等同于制造企业。 FD...
当前API的cGMP规范包括进行科学合理的原材料测试(raw material testing)、工艺过程监控(in-process control)、放行(release)和稳定性测试(stability testing)、工艺验证(process validation)以及对从此类测试中产生的任何OOS结果进行充分调查。合同测试实验室(contracting laboratory)对于...
General Principles of Process Validation May 1987 GENERAL PRINCIPLES OF PROCESS VALIDATION I. PURPOSE This guideline outlines general principles that FDA considers to be acceptable elements of process validation for the preparation of human and animal drug products and medical devices. II. SCOPE This ...
关于FDA所认为适当的工艺验证要素的一般原则和方法,参见FDA指南文件Process Validation: General Principles and Practices,url。 在对此函的回复中,请提供: 1)一份对确保产品整个生命周期内受控状态的验证计划以及相关规程的详细总结。请描述工艺性能确认计划,以及对批内和批间变异的持续监控,以确保持续受控状态。2)一...
PK(Pharmacokinetics):药物动力学 PD(Pharmacodynamic):药效学 Photodiode Array Detector:光电子二极管列阵监测器 Potency:效力或效量 Pre-Clinic Study:临床前的研究 Process validation:工艺验证 Products annual review:年度产品回顾 Product recalls:产品回收/产品召回。
Preparing and Submitting:起草和申报 Process validation:工艺验证 Products annual review:年度产品回顾 Product recalls:产品回收/产品召回。 Proprietary name:专有名称 Protocol:方案 R Review copy:审查用副本 S Submission:申报;递交 Sponsor:主办者(指负责并着手临床研究者) ...
GeneralPrinciplesofProcessValidationMay1987 GENERALPRINCIPLESOFPROCESSVALIDATION -1- Inshort,thisguidelinelists Interested I.PURPOSE ThisguidelineoutlinesgeneralprinciplesthatFDAconsiderstobeacceptableelementsof processvalidationforthepreparationofhumanandanimaldrugproductsandmedicaldevices. II.SCOPE Thisguidelineisissued...