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GMP News

EMA: QPs must provide a written final Assessment and Approval of Third-Party Audit Reports

EMA has published updated GMP Q&As on with two new questions dealing with third party audits. QPs should provide a written final assessment and approval of third-party audit reports.

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EDQM: Excipient Monographs and Reference Standards

In the last few months, some excipient monographs have been updated and new reference standards have been included in the European Pharmacopoeia (Ph.Eur.). Supplement 11.6, which was introduced on the 1st of January 2025, for example, contains some revised texts.

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EMA publishes four new product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published the finalised product-specific bioequivalence guidelines for Budesonide and Tolvaptan. The documents will come into effect on 1 September 2025.

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