Project Summary / 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.
