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GMP News

USP publishes Comments rereived on Chapter <317>

In its recently published USP-NF 2026 Issue 1 Commentary (posted 25 July 2025), the United States Pharmacopeia (USP) addressed public comments received on the draft of General Chapter <317> ICP-OES Testing for Sodium Hydroxide and Potassium Hydroxide.

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FDA assesses economic Benefits of investing in Quality Management

The FDA evaluates investments in quality management initiatives in a publication. Even small investments in, for example, quality culture can be profitable. However, it also warns against overinvestment.

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How to Deal with Audit Trails in Preconfigured Equipment?

In preconfigured equipment, you cannot set or configure the audit trail. How do you deal with this?

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