What Deviations can be found in FDA Warning Letters: Lack of GMP Training and related Documentation

Training in Good Manufacturing Practices (GMP) is essential for employees, specialists, and managers in GMP-regulated manufacturing, forming the foundation of a compliant pharmaceutical quality system. Many GMP violations leading to FDA Warning Letters stem from inadequate training.

Proper GMP training ensures high-quality product manufacturing. An FDA Warning Letter states that "training is essential to ensure proper performance of job functions" (Samchundang Pharm Co., Ltd., May 2020). U.S. regulations mandate adequate employee training, with §211.25 CFR requiring personnel involved in drug manufacturing to possess the necessary education and ongoing training conducted by qualified individuals.

Despite these regulations, insufficient training is frequently cited in FDA inspections. Recent Warning Letters identified various deficiencies, such as inadequate employee qualifications, incomplete training records, and insufficient quality oversight.

These findings highlight the FDA's expectations for regular training and proper documentation. Ongoing training issues contribute to compliance violations, underscoring the need for well-trained personnel to maintain GMP standards in pharmaceutical companies.