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GMP News

Is QP Release possible after deviating In-Process Controls?

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations during from in-process controls?

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USP: Chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' final

The comment periods for the USP chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' closed at the end of 2024. In the meantime, both chapters have been finalised and are now available for viewing. Both documents are set to become officially valid in February 2026.

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EMA updates IRIS Documents

In July 2025, updated versions of the two guidance documents 'IRIS guide for applicants' and 'IRIS guide to registration and RPIs' were published. Version 3.9 of the 'IRIS guide for applicants' and version 2.18 of the 'IRIS guide to registration and RPIs' are now available on the EMA website.

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