Strengthening global competency & capacity in inspectional approaches through the implementation of a web-based educational centre for pharmaceutical inspectors worldwide

This Cooperative Agreement award from the Food and Drug Administration (FDA) under the Food and Drug Administration Research program (CFDA 93.103) provides $150,000 in funding to the Pharmaceutical Inspection Co-Operation Scheme-Association De Droit Suisse to develop curricula and training tools for a web-based educational center called the PIC/S Inspectorates' Academy (PIA). The goal is to harmonize and standardize Good Manufacturing Practice (GMP) training and qualification processes for pharmaceutical inspectors globally through the PIA. Key deliverables include developing harmonized curricula for training inspectors in specific areas like active pharmaceutical ingredients, sterile products, and biologics, integrating the curricula into a learning management system, and launching the training program including training inspectors and tutors/mentors. This project aims to support the FDA's efforts to improve pharmaceutical quality, apply GMP regulations, and conduct risk-based facility assessments, as well as address challenges from globalization by sharing resources and building global inspection capacity.

Abstract

The training of good manufacturing practice (GMP) inspectors has been one of the pharmaceutical inspection CO-operation scheme (PIC/s)' main focal points since its very beginning in 1971. In order to further support this goal, IT launched the PIC/s inspectorates' academy (PIA), a web-based educational centre under the PIC/s umbrella aiming at harmonising and standardising GMP training and qualification process at an international level through a recognised qualification system. The development of the PIA is being carried out in stages. Stage two, which is the object of this project, is the most important and critical phase of PIA's development. IT is largely based on the development of a harmonised PIA training programme (TP) including curricula and training content. PIA pursues three main objectives through the implementation of stage two, namely to:  ensure harmonisation through standardisation/calibration of GMP knowledge, skills and expectations resulting in the definition of a PIA TP on how to train and qualify inspectors, based on minimum requirements;  develop proposed training tools and curricula within the frame of the PIA TP resulting in making available high quality harmonised training, cost effective and primarily web-based, through a set of e-learning modules responding to specific needs;  encourage increased mutual reliance through the implementation of the above objectives. The project funding aims to implement the curricula, crucial element of the PIA TP, through the following activities and deliverables:  developing curricula based on harmonized minimum requirements for the training of inspectors in specific fields (e.g. API, sterile products, biologicals, etc.);  integrating the curricula into the learning management system and conduct necessary testing phases;  launching the curricula including training inspectors and tutors/mentors on its use. PIA, as a PIC/s global training initiative, has the potential to support US FDA's efforts toward the improvement of pharmaceutical quality, application of GMP regulations and risk-based assessment of facilities as well as addressing the challenges resulting from globalization, in particular by the sharing and leveraging of resources and facilitating capacity-building.