Chapter 11: Training and Personnel Qualifications

Good manufacturing practices (GMP) require that personnel have the education, training, and experience needed to perform their assigned responsibilities. Inadequate training can cause the United States Food and Drug Administration (FDA) to declare the product to be adulterated under the Food, Drug, and Cosmetic Act (FDCA), potentially preventing the product from being sold or distributed. Training on both specific job tasks and GMP is required.

Job-Specific Training

Managers (or supervisors) are responsible for defining the training needed for a specific position in a list of required documents and training courses such as a job curriculum. If retraining needs to be performed periodically, such as for aseptic practices, the curriculum can indicate this timing requirement. The curriculum should indicate what training is needed before specific tasks can be performed by the employee. Training is done and documented before an employee performs the task.

Training should not be considered a one-time exercise that is provided only when an employee is hired. Training related to job tasks is necessary when procedures, batch records, and/or test methods are revised or when a task has not been performed recently. Similarly, when an employee’s job changes within an organization, his or her education, experience, and training should be reevaluated to determine what areas need to be addressed to perform the new job. Changes in work experience and education can be documented by maintaining an up-to-date resume or work history in the employee’s training file.

Defect awareness training should make personnel aware of the need to understand that if they do not follow procedures, batch records, or test methods as written, an adverse impact to product quality may occur.

Good Manufacturing Practices Training

Many pharmaceutical companies provide annual GMP training courses. These courses may include topics such as recent trends in the GMP industry, new or newly revised GMP regulations, summary of deviations and internal audit observations that have occurred in the past year, or a review of GMP regulations that impact the organization. In addition, if a pharmaceutical manufacturer has been distributing its products solely within the United States and gains approval to sell its products in Canada, it would be beneficial to train employees on the Canadian GMP, although they closely resemble the FDA GMP. Pharmaceutical manufacturers also should train employees on the specific GMP related to their jobs.

FDA’s Quality Systems Approach to Pharmaceutical CGMP Regulations guidance document indicates that quality unit (QU) personnel should have some understanding of scientific and technical topics, product and process knowledge, and the ability to assess risk. The QU has many responsibilities, the most important of which is releasing or rejecting product. For this responsibility, quality unit personnel should be trained to identify any deviations in manufacturing or testing processes that may not have been observed and addressed during manufacturing and testing, and to conduct effective investigations to determine whether product quality was impacted. If product quality was adversely impacted, or if the impact to product is unknown, the product should not be released.

European GMP regulations include specific requirements for training of personnel whose duties involve manufacturing or quality control (QC)–related activities. These are discussed in EudraLex, Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union. Training also applies to visitors or untrained personnel who must enter production or QC areas. These individuals must first receive information on personal hygiene and use of protective clothing, and should be closely supervised.

European training requirements include basic training on GMP as well as ongoing training. The concept of quality assurance (QA) and its implementation should be addressed in GMP training. Specific training should be given if personnel work in areas where contamination may be a hazard. EudraLex specifies that the training programs be approved, preferably by the head of production or quality control, as appropriate, and records of training must be maintained. Effectiveness of training should be assessed as well. World Health Organization (WHO) GMP training requirements are similar to those discussed in EudraLex and also include a requirement for contractors and consultants to receive training.

Training Effectiveness

According to Quality Systems Approach to Pharmaceutical GMP Regulations, managers (supervisors) are responsible for ensuring that training is effective by verifying that the skills are learned and implemented in their employees’ daily performance. Management is also responsible for communicating employee roles, responsibilities, and authorities within the quality system and ensuring that interactions between different roles are defined and understood.

Any evidence that indicates the employee’s training was not effective, or that they do not have the appropriate experience or skills (for example, frequently occurring deviations when executing tasks), should trigger an evaluation of whether the employee is capable and/or whether additional training or retraining is needed. If the original training was not effective, simply retraining an employee may not be sufficient to resolve performance issues. The training may need to be redesigned to be effective.

Employee Qualifications

Managers need to define the qualifications for a position (which is usually defined by a job title). The responsibilities for a specific position are defined in a document such as a job description. In addition to responsibilities, the job description can include minimum education and experience requirements, skills, and required certifications. Certifications provide a good yardstick for knowledge of a topic because a body of knowledge (BoK) is measured by an examination, but they do not replace the experience and hands-on training provided by performance of a job or task. ASQ certification is peer recognition that an individual has proficiency with, and comprehension of, a specified BoK. A clear job description facilitates hiring the best person for the job.

Job descriptions for personnel who perform testing and/or calibration tasks have specific minimum requirements as outlined in ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories. These requirements include:

• Responsibilities for performing and planning tests and/or calibrations and evaluating the results, reporting opinions and interpretations, and modifying, developing, and validating new methods.

• Expertise and experience required includes qualification and training programs and managerial duties.

Documentation of Training

All training should be documented by recording the topic and an overview of the content, the trainer, the date trained, and the trainee’s name. Regulatory agencies expect to see documentation that trainers are qualified, as well. For example, a GMP trainer should have experience and training in GMP in addition to knowledge of the topic of the training program. It is important that training records be maintained, as well, to provide evidence of employee competency.

Employee Proficiency

Proficiency for a particular task should be documented before the employee performs the task independently. For critical tasks (those that could impact product quality), task training can be performed to ensure that the employee thoroughly understands the task. Task training consists of the trainee reading any related procedures, observing the task being performed by a qualified individual, performing the task under the supervision of a qualified individual with assistance and coaching, if needed, and performing the task independently. The trainer indicates on the training documentation that the trainee satisfactorily completed training, and the employee indicates that he or she understands the task and associated documentation.

Proficiency for gaining knowledge from training can be assessed by administration of a test after the training event. Verification that knowledge was gained during the training session can be accomplished by administering a pretest before the training event occurs and comparing the results to the post-training test. A minimum passing grade is typically defined for GMP tests. Retention of the knowledge gained by attending the training could be assessed by testing a trainee when time has elapsed after the training event occurs.