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GMP News

Analytical Quality Group Developments May through August 2026

Find out what the ECA Analytical Quality Control Group was working on and accomplished in the second four months of 2026 - in the latest report.

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Validation Group Update May-August 2026

Find out what projects the ECA Foundation's Validation Group was working on between May and August 2026 and what they accomplished - in their current Group Update.

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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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