What does Annual (Product) Review mean?

03.02.2025

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An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. [Guidance for Industry: Quality Systems Approach to Pharmaceutical GMP Regulations, FDA]

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24.11.2025

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How is a QRM process initiated?

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FDA: Updated Pre-RFD Guidance for Combination Products

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EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

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