CDER Quality Management Maturity - FDA
2024年12月31日 · FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing …
QMM is the state attained by having consistent, reliable, and ro-bust business processes to achieve quality objectives and promote continual improvement. Gauging QMM requires, in part,...
2023年4月12日 · “FDA should lead the development of a framework to measure... a facility’s quality management maturity with engagement from industry, academia, and other …
Quality Management Maturity for Finished Dosage Forms Pilot …
2020年10月16日 · The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing its Quality Management Maturity for Finished …
Complete guide to the FDA Quality Management Maturity program
The FDA's QMM program promises a radical shake-up of how pharmaceutical quality is perceived, measured and rewarded. Learn how to align with the program and use it to your …
FDA发布质量管理成熟度2023年白皮书 - 知乎 - 知乎专栏
2023年8月31日，fda发布标题为“cder的质量管理成熟度（qmm）计划：实践领域和原型评估方案开发”的白皮书，这是对 2022年qmm白皮书计划的延续。 书中表示，CDER正在建立一个计 …
Pharma “Quality Management Maturity” (QMM), an initiative by US FDA …
2025年2月5日 · FDA has conducted two pilot programs with pharmaceutical manufacturers to inform the criteria used to objectively measure a manufacturing site’s QMM. One pilot is …
PDA and FDA Continues Collaboration on QMM Conversation
2023年10月12日 · 2023 – The FDA published CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, where the Office …
FDA 质量管理成熟度计划新进展 - 识林
FDA强调，实现QMM需要监管创新数据的支持，并首次提出数据分为滞后指标（Lagging indicators）和领先指标（Leading indicators），而这两个概念也是FDA引自上文提到的北京 …
What You Need To Know About Quality Management Maturity
2023年1月3日 · The introduction of the Quality Management Maturity (QMM) system by the Center for Drug Evaluation and Research (CDER) at the U.S. FDA aims to ensure that drug …