Training for GMPs

Abstract

Training is a dynamic process to assure that personnel are capable of performing their assigned functions. CGMP regulations contain only general expectations, and no FDA guideline regarding training has been issued. Training programs are generally in place in pharmaceutical firms. However, training quality and effectiveness may be inadequate in a number of firms. A pharmaceutical firm should be able to show that its training program consistently meets its training goals as purported, and that each trainee completing an instructional module has acquired the competencies as purported. The proper application of sound principles of instructional design should help firms overcome GMP deficiencies regarding training and personnel qualification. For example, principles of mastery learning, competency-based instruction, performance objectives, a systems approach to instructional design, and the evaluation of instruction as well as the instructional program should help ensure meaningful, relevant training and appropriate, effective instruction. Review of training should be included in the firm’s program for managing change. Firms should also ensure adequate training documentation, a positive attitude toward training, and that training is not used inappropriately to remedy performance deviations not resulting from skills deficiencies.