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GMP News

FDA Publishes Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms

On 30 October 2024, the Center for Drug Evaluation and Research within the U.S. Food and Drug Administration has published a Guidance for Industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms". The document is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases.

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USP Seeks Early Input on Proposed New General Chapter <318>

The USP has published a General Chapter Prospectus for a new USP General Chapter <318> NMR Spectroscopy Monomer Ratio Determination for Lactide-Glycolide Polymers. The USP is requesting early input from stakeholders on this proposal, with an input deadline of 24 November 2024.

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FDA Warning Letter to a US Manufacturer of Medical Gases

The FDA inspected a production facility of a US medical gas manufacturer in Pennsylvania (USA) in March 2024 and identified significant GMP violations.

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