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GMP News

USP-NF Publishes Responses to Comments on Stimuli Article on Apex Vessel Geometries

In the Pharmacopeial Forum, PF 52(5), the USP has published its responses to comments on the Stimuli article “Characterization of Apex Vessel Geometries and Irregularities”. The original article examined the geometrical characteristics and irregularities of commercially available apex vessels used with USP Apparatus 2 in dissolution testing. The responses indicate that further studies are planned before scientifically justified specifications and tolerances for apex vessels can be established.

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How GMP Non-Compliance can stop a Marketing Authorisation Application

An EU-based sponsor has withdrawn its marketing authorisation application for a monoclonal antibody submitted to the European Medicines Agency (EMA), following unresolved concerns about the contract manufacturing site's GMP compliance that had also affected the FDA approval process.

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PFAS restriction: Commission highlights Importance of critical Medical Applications

The European Commission has responded to a parliamentary question on the potential impact of the planned PFAS restriction on medical devices, highlighting the particular importance of critical applications in healthcare. However, no specific exemption for certain medical devices has yet been confirmed; the final rules remain open pending completion of the assessments.

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