Requirements of FDA for Training in Pharmaceuticals

The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirements. The FDA GMP training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects.

1. Employees Involved in Manufacturing, Warehousing or Packaging Each employee that has a role in the production or storage of a drug needs to have sufficient education, training, experience or any possible combinations. Each employee has to be trained in the exact process or operation he is involved in and must be given detailed information.

The training of each employee must include the CFR regulation and the written procedures specific to his role in the company. The training can only be delivered by qualified personnel and has to be frequent enough in order to make sure the employee is familiar enough with all the requirements specific to the role.

2. Supervisors The second group of interest is represented by the supervisors of the employees above. Every supervisor involved in any of the stages of the development, manufacturing, and storage of the drugs needs to be properly trained to be able to ensure the safety and the quality of the drugs.

3. Sufficient Qualified Personnel
The third issue covered by the Code of Federal Regulations that relate to training refers to the number of qualified personnel that is properly equipped and qualified to either perform or supervises the entire process.
In other words, the pharmaceutical company needs to make sure that they have enough qualified personnel to manufacture the drugs and supervise the process.
This is an important issue because fewer employees mean a high workload which in fact leads the employees to a sloppy work and mistakes the pharmaceutical industry can’t afford.

The Training Programs
The senior management team is responsible to ensure successful training programs for all employees. Such a program must include the following:

• A Proper Evaluation of Company’s Training Needs
This includes specific training schedules and information for each function and employee. The training information must include CSR regulations and specific training plan that includes all the procedures specific to that job function.

• The Delivery of the Training
The next step is to actually train the employees with qualified instructors. The training has to be specific and provide all the necessary information to the employee and, if possible, study cases and scenarios.
The training must include corporate training requirements (safety, orientation, and quality systems), training requirements specific to the job, re-training information.
Re-training will be conducted on a regular basis but also when there is a change in SOPs (standard operating procedures) or the first training proved to be ineffective.

• The Evaluation of the Training
The effectiveness of the training provided must be constantly evaluated. A method for evaluation of training can be a test given to the employee on the last day of training and constant supervision.

• Documents Keeping
Detailed records and documents that illustrate the training already provided, the content, the results and the date the next training session should be delivered to each employee. All the documents related to personnel training will be reviewed during an FDA GMP inspection.

In pharmaceutical industry, a proper training of the personnel is crucial. To meet the FDA requirements the company needs to develop a complete, detailed training program that will lead to a successful training of all its employees.

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