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GMP News

ECA's Analytical Control Group Publishes Detailed Report on OOS Survey

As previously reported, the ECA Analytical Quality Control Group (AQCG) conducted a survey on Out-of-Specification (OOS) results. Following the recent publication of a short summary, a detailed report is now available, complemented by a recorded video discussion highlighting key findings. Both are available free of charge in the group's members' area.

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When Training Fails: FDA Warning Letters Highlight GMP Training Deficiencies in 2026

Adequate training of personnel in the GMP-regulated environment is fundamental to a compliant pharmaceutical quality system. However, insufficient employee training has been a frequent finding in FDA inspections so far in 2026.

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BP Publishes Key Insights on Limits in Chromatographic Tests

The British Pharmacopoeia (BP) has published a new "Key Insights" article focusing on the topic of limits in common BP monograph tests, specifically chromatographic limits in related substances tests and assay.

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