FDA and EU Regulators Find Data Integrity Lapses Are Still a Major GMP Problem

Executive Summary The large number of US FDA warning letters going to firms for data integrity failings is mirroring trends with EU regulatory authorities, who are flagging data integrity failings in almost half of their GMP non-compliance reports. The issue strikes close to home for one FDA official.

Executive Summary

The large number of US FDA warning letters going to firms for data integrity failings is mirroring trends with EU regulatory authorities, who are flagging data integrity failings in almost half of their GMP non-compliance reports. The issue strikes close to home for one FDA official.

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Source: pink.pharmaintelligence.informa.com