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GMP News

Two New FDA Warning Letters Put OOS Investigations in Focus

Two new FDA Warning Letters address, among other issues, significant deficiencies in out-of-specification (OOS) investigations. Both letters underline that retesting, procedural changes or a revised specification cannot replace a scientifically sound investigation, a detailed root cause analysis and an assessment of potential impact on other batches and products.

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USP Revises the Pharmaceutical Water Monographs

In September 2026, the USP published numerous revisions to the water monographs on the USP-NF website. In addition to the monograph <1231> Water for Pharmaceutical Purposes, the revisions affect the monographs for sterile waters and the pure steam monograph. The revised texts will become official on 1 April 2027.

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Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination

A draft revision of European Pharmacopoeia (Ph. Eur.) general chapter 2.5.32. Water: micro determination has been published in Pharmeuropa 38.4. The public consultation deadline is 31 December 2026.

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