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。
1 FDA Guidance for Industry:Process Validation: General Principles and Practices, 2011年 2 PDA Technical Report NO 60:Process Validation: A Lifecycle Approach, 2013年 3 CMCBiotechWorking Group, A-Mab, a Case Study in Bioprocess Development. 2009年 4 J. Felix Kepert et al, Establishing a cont...
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 ...
FDA is to be commended for taking the initiative and introducing this new guidance.David LeBlondJournal of validation technologyLeBlond D. FDA Bayesian statistics guidance for medical device trials - application to process validation. Journal... D Leblond - 《Journal of Validation Technology》 被引量...
Guidance for Industry PAT — A Framework for Innovative Pharmaceutical SN - 979-953-307-457-2. US Food 被引量: 133发表: 2004年 A Review of Process Analytical Technology (PAT) in the U.S.Pharmaceutical Industry Process Analytical Technologies (PAT) are used to provide timely analysis of criti...
In Chap. 3, the first stage of the FDA's 2011 process validation guidance was described demonstrating various options to drive process understanding using experimental design . The resulting process design experiments yield information that can be used to define future operating ranges for the new pr...
FDA’s guidance document on Process Validation: General Principles and Practices may help you understand our current thinking on approaches to process validation. The guidance is available athttp://www./downloads/Drugs/Guidances/UCM070336.pdf. ...
process control to ensure stable manufacturing operations andconsistent drug quality. See FDA’s guidance document, Process Validation:General Principles and Practices, for approaches that FDA considersappropriate elements of process validation, athttps://www.fda.gov/downloads/drugs/guidances/ucm070336....
The guidance describes proper prevention of andtesting for BCC in aqueous dosage forms of NSDs. 为了说明微生物风险评估和控制策略的重要性,本指南讨论了洋葱伯克霍尔德菌复合体(BCC)事件和其它非无菌制剂的微生物污染导致不良事件和产品召回的情况。本指南阐述了 NSD水性制剂中 BCC的恰当预防和检测。 The ...
6关于医疗机构再生处理后的可重复使用器械(以及需要在医疗机构进一步灭菌的非无菌一次性器械)的清洁、消毒和灭菌的信息。见 “医疗机构中医疗器械的再生:验证方法和贴标”(见 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulat...