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

GMP training for employees, specialists and managers in GMP-regulated manufacturing is the basis of a compliant pharmaceutical quality system. A large number of GMP violations that lead to FDA Warning Letters (and also EU Non-GMP Compliance Reports) are caused by a lack of GMP training.

Sufficient GMP training of employees is vital for GMP-compliant manufacturing of high-quality products. As stated in an FDA Warning Letter: "Training is essential to ensure proper performance of job functions" - Samchundang Pharm Co., Ltd., May 2020.

National regulations around the world require sufficient employee training. In the United States, requirements for employee training are laid down in §211.25 CFR:

"(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."

Compliance with this regulation is monitored during FDA inspections.

However, from all of the Warning Letters issued, insufficient employee training is a frequent finding in FDA inspections.

In the following, some of the most recent findings cited in Warning Letters related to deviations to 21 CFR 211.25 are listed:

• Kaylaan LLC, August 2024
  Finding: Quality Unit did not adequately verify that each person engaged in the manufacture, processing, packing, or storing of a drug product has the required education, training, and experience.
• Max Chemical Inc., June 2024
  Finding: The Quality Control Unit failed to ensure employees engaged in manufacturing, processing, packing, or holding of drug products were adequately trained.
• QuVa Pharma, Inc., January 2024
  Finding: Inadequate training records.
• Colgin, Inc., January 2024
  Finding: Insufficient Quality Oversight whereas the Quality control failed to provide adequate training for employees engaged in the manufacture, processing, packing, or holding of drug products.

Additional findings in FDA Warning Letters are listed below:

• The Quality Control Unit did not provide proper training for employees engaged in the manufacture, processing, packing, or holding of the hand sanitizer product. The Warning Letter can be found here.
• Training for laboratory personnel was not consistently conducted and documented by qualified individuals. The training system was set up one week before the inspection. The Warning Letter can be found here.
• Failure to ensure personnel in the management, production, quality assurance, and quality control departments have the education, training, and experience to perform their job functions. E.g. Failure to properly train employees in manual visual inspection. The Warning Letter can be found here.
• Inadequate documentation of training records and  staff competence. Lack of a comprehensive training plan to enable staff to carry out their designated role correctly. The Warning Letter can be found here.
• Failure to ensure staff engaged in microbiological testing have the necessary education, training, and experience to perform their job function.The Warning Letter can be found here.
• Failure to ensure that employees are adequately trained, with no CGMP related training documentation available. No CGMP training has ever taken place. The Warning Letter can be found here.

These Warning Letters outline the FDA's expectations for GMP training. Each employee involved in the manufacture, processing, packing, or holding of a drug product must be properly trained and retrained. Training and retraining should be conducted on a regular basis by a qualified trainer. Training is required to be documented. The success of the training should be assessed.

The findings also show that inadequate employee training is an ongoing problem and the root cause of many other violations in FDA Warning Letters. Trained personnel who are aware of CGMP regulations are essential for GMP compliance in pharmaceutical companies.