FDA Highlights Persistent GMP Training Deficiencies in 2025

Proper training of personnel is foundational to a compliant pharmaceutical quality system, ensuring product quality, regulatory adherence, and patient safety. Insufficient GMP training remains a frequent cause of FDA Warning Letters and EU Non-GMP Compliance Reports. Under 21 CFR 211.25(a), employees engaged in the manufacture, processing, packing, or holding of drug products must possess the education, training, and experience necessary to perform their roles effectively.

In 2025, the FDA has cited multiple companies, including Rite-Kem, Yangzhou Sion, BioAsia, PMS4PMS, Staska Pharmaceuticals, and Exela Pharma Sciences, for failing to provide adequate GMP training. Deficiencies highlighted include lack of oversight by quality units, absence of established training programs, and failure to ensure ongoing competency assessments.

The FDA emphasizes that training must be documented, regularly conducted, and assessed for effectiveness. Persistent training gaps often underlie other GMP violations, reinforcing the critical role of continuous personnel qualification in maintaining regulatory compliance and safeguarding patient safety.

22-09-2025