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。
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指导性文件《工艺验证:一般原则和惯例》,以获取FDA关于工艺验证适当...
This guidance outlines the general principles and approaches that FDA considers appro- priate elements of process validation for the manufacture of human and animal drug and biological products, including active pharma- ceutical ingredients (APIs or drug sub- stances), collectively referred to in ...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指南《工艺验证:一般原则和实践》,就FDA考虑的工艺验证适当要素,获取...
24.Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry, July 2015, available at: https://www.fda.gov/media/87801/download. 25.Process Validation: General Principles and Practices; Guidance ...
Guidance for Industry1 行业指南1 Process Validation: General Principles and Practices 工艺验证:一般原则与实施 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 ...
• In Stage 3, continued process verification, ongo- ing assurance is gained during routine produc- tion that the process remains in a state of control. In addition to discussing activities typical of each stage of process validation, the 2011 Guidance pro- ...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指南《工艺验证:一般原则和实践》,以获取FDA认为工艺验证适当要素的...
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...
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...