Enhancing Quality Through Training
Posted: 11 December 2024Ensuring the quality and safety of drug products is crucial and can only be achieved when all personnel involved in pharmaceutical manufacturing have the training necessary to consistently perform their jobs at a high level even as technologies advance and processes evolve. To avoid process variability, safety issues, and regulatory compliance concerns, training should be conducted for R&D and manufacturing personnel on an ongoing basis and encompass technical, procedural, and safety aspects.
Training should cover proper use of equipment in a GMP setting, how to follow appropriate procedures and keep good batch records, contamination control, storage and handling requirements, aseptic manufacturing practices, current regulatory requirements, appropriate maintenance practices, and how to deal with unexpected events, including responding to them and documenting them. As importantly, personnel should be taught why each unit operation matters and what is accomplished, and training programs should be regularly updated to reflect advances in technology (equipment, automation, modelling and statistical programs, digital technologies, etc.). Hands-on training in a stress-free environment is particularly important for operators.
Training records must be maintained in a manner that allows for tracking and assessment of completed training for all personnel. Collaboration with academic institutions and industry groups can support robust training programs by augmenting in-house activities. For new modalities such as viral vectors and gene therapies, incorporation of information about advances in the field can be achieved through ongoing review of the literature and engagement/networking across the industry.
Read more in the full article: Susan Haigney, “Enhancing Quality Through Training,” Pharmaceutical Technology, 48 (12), December 2024, pp. 10-15.