Inspection Excellence Through Harmonised Training

The PIC/S Inspectorates' Academy (PIA) is a PIC/S initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonising and standardising GMP training at an international level through an accredited qualification system. PIA delivers not only general or advanced training but also serves as a platform for discussion and sharing among regulators. It offers a single point of access to all PIC/S training activities and will be implemented in various stages.

Presentation of the PIC/S’ Inspectorates Academy (PIA) at PIC/S’ 50th Anniversary in Dublin (Ireland) on 4 October 2022.

Welcome to PIA!

The PIA is a webportal to all PIC/S training activities where you will find:

Information on all PIC/S training activites and tools;
A calendar of upcoming PIC/S training events;
Available video recordings of PIC/S training events;
A database compiling all PIC/S training materials available;
A forum for discussion and sharing among regulators.

Background of PIA

The idea of a PIC/S Training Academy was announced during the PIC/S 40^th Anniversary Symposium in 2011. The concept was originally mooted by Mr Boon Meow Hoe (Singapore / HSA), that PIC/S creates a professional “Inspectors’ Academy” (“PIA”) delivering a variety of courses ranging from general training to highly specialised training for Inspectors. In 2012, an Ad-Hoc Working Group was set up with a view to explore how to create the PIA, with an objective to provide cost-effective, primarily web-based, high quality harmonised training for Inspectorates. In 2013, a training survey was carried out by PIC/S among its Members and Applicants. Based on the outcome of this survey, a road-map of different possible steps and features of the PIA was developed, for which a PIA Project Management Steering Committee (PIA PMSC) was appointed by PIC/S.

Why the PIA

In 2014, PIC/S decided to establish the PIA for the following reasons:

• need to have a formal “educational centre” under the PIC/S umbrella. Considering the success of PIC/S training activities, the need for an internationally accredited training curriculum including different modules and specific training in the field of GMP as well as in other Good Practice fields (GxP) emerged. The training of Inspectors and the various training tools are fundamental for the harmonisation of GMP, which is intrinsic to PIC/S’ mission "to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of Inspectorates in the field of medicinal products." 
• need to have a formal programme for “Calibration” / “Qualification” of GMP knowledge inspection skills and Inspectors’ expectations. Harmonisation efforts are key and training is the very cornerstone of harmonisation and its beneficial outcome. The PIA aims to train Inspectors and Regulators, mainly by Inspectors and Regulators themselves. This “educational centre”, may be one of the most effective ways to harmonize in depth at a global level.
• strong support for the PIA project from Heads of Agencies, PIC/S Members (and non-Members) as well as interested Partner Organisations and Third Party Professional Associations. 
• key benefits of the PIA for PIC/S and its Members, among which the ability to respond to current and future needs in terms of training of Inspectorates. 
• relevance to current global objectives of international co-operation. The PIA, as a global PIC/S training initiative, would have an important role to play in helping address some of the very actual concerns such as encouraging global convergence in pharmaceutical and API manufacturing quality and inspection processes, addressing the challenges resulting from globalisation, in particular by the sharing and leveraging of resources, facilitating capacity-building, etc.

Access to PIA

The aim of the PIA is to train GMP Inspectors/Regulators by Inspectors/Regulators. PIA’s training is restricted to PIC/S Participating Authorities Regulators only. The PIA not only delivers training but also serves as a platform for discussion and sharing among PIC/S Participating Authorities Regulators with a view to responding and identifying needs as well as contributing to global harmonisation and interpretation of GMP. Access to training material is limited to PIC/S Participating Authorities Regulators. Stage 1 of the PIA is open only to PIC/S Members. Login is required. The training materials available through the PIA are supplementary to existing PIC/S training activities and tools.

Stages of PIA

The development of the PIA is being carried out according to the following stages which are being implemented one after the other by the PIC/S Project Management Steering Committee (PMSC). Each of the stages are independent from each other.