实施上市后合规和产品成功的持续工艺验证计划:在2025年PDA周上展示的海报。

Q3 Medicine
Anthony Stewart
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引用次数: 0

摘要

持续工艺验证(CPV)是FDA工艺验证指南的第三阶段,是现代制药生产的关键组成部分,确保工艺在整个产品生命周期中保持受控状态。然而,CPV一直被忽视,许多公司没有意识到CPV计划的实施是一项监管要求。这张海报使用一个案例研究来描述成功实施CPV计划的关键步骤,使用分阶段方法对遗留产品、已批准产品以及进入工艺验证的产品实施CPV计划。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Implementation of Continued Process Verification Program for Post-Market Compliance and Product Success: Poster Presented at PDA Week 2025.

Continued Process Verification (CPV) is the third stage of the FDA Process Validation guideline and is a critical component of modern pharmaceutical manufacturing, ensuring that processes remain in a state of control throughout the product lifecycle. However, CPV has historically been overlooked, with many companies unaware of the need for CPV program implementation as a regulatory requirement. This poster uses a case study to describe the key steps for successful CPV program implementation using a phased-approach for both legacy, approved products, as well as products entering process validation.

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CiteScore
1.90
自引率
0.00%
发文量
34
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