Active Pharmaceutical Ingredients

The PIC/S Expert Circle on Active Pharmaceutical Ingredients (API) was established in 2005. It has been very active in developing and maintaining a common approach and equivalent interpretation of the ICH Q7 Guideline. Q7 is originally based on a PIC/S draft guideline on API, adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007. The PIC/S Expert Circle on API has also developed a PIC/S Aide Memoire on API and Q&A on API distribution in addition to more recently contributing to the ICH Q&A document on Q7. An API International Training Programme has been set up by this Expert Circle for Inspectors and - for some training segments (Q7) - also for industry.

PIC/S API Expert Circle Madrid
PIC/S Expert Circle on API, Madrid (Spain), 2019

Expert Circle Chairmanship

The PIC/S Expert Circle on API Chairperson is currently vacant.

Key Features

The goals of the PIC/S Expert Circle on API are, among others, to:

  • develop and maintain, in collaboration with selected pharmaceutical industry associations, an international training programme on inspection of API manufacturers for Inspectors and, for some training segments, for industry. For more information see PIC/S API International Training Programme.
  • promote and support participation in existing PIC/S visit programmes (such as joint visit and coached inspection programmes) and help develop new joint API inspections in order to reinforce co-operation in the field between PIC/S Inspectors and between PIC/S Participating Authorities and PIC/S Partner Organisations.
  • respond to specific needs and expectations of PIC/S Participating Authorities, including the provision of expertise on inspectional and technical knowledge e.g. in relation to complex API inspections as well as to provide updates (e.g. scientific publications (see Press) and training on key issues (e.g. cleaning validation, process validation, data integrity, QRM, critical parameters, etc.)
  • identify current trends and inspections practices, on a continuous basis, by way of data trending, in order to cover future training needs as well as address potential controversial issues and favour harmonisation between different possible approaches.
  • develop a database of “experts” and a database of API Inspectors in order to create a global knowledge network, with a view to facilitate the dissemination and sharing of information and knowledge.
  • foster and explore any means of improving international co-operation in the field of API inspections in order to develop a uniform consistent harmonised interpretation of international requirements based on Q7 and ensure that the principles and GMP described in Q7 are clearly understood by industry, and consistently applied by the different Regulatory Authorities (PIC/S Participating Authorities and non-PIC/S Member Authorities).
  • develop PIC/S Guidelines/documents on API (including data integrity and distribution issues) and to provide expertise during the revision and/or development of any other GMP Guidelines/documents related to API. 

Guidance Documents

A number of Guidance Documents have been developed by the Expert Circle on API, which are publicly available under  "Publications".

API International Training Programme

The PIC/S International API Training Programme (API ITP) consists of 3 segments related to the PIC/S GMP Guide, Part II (ICH Q7). The segments include (i) General Training on ICH Q7, which is open to Regulators and Industry; (ii) Advanced Training which is open to Regulators only and (iii) Q&A for Regulators and Industry.

Past Expert Circle Meetings

Madrid  | Spain 2019
Melbourne | Australia 2017
Strasbourg | France 2015
Rome | Italy 2014
Washington DC | USA 2012
Singapore | Singapore 2011
Dublin | Ireland 2010
Basel | Switzerland 2008
Paris* | France 2007
Paris | France 2005
* Meeting of the Working Group on the drafting of the PIC/S Aide Memoire on API

Upcoming Expert Circle Meetings and Training Activities

Expert Circle Meetings and related Advanced API Training are only open to inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and Non-Member National Drug Regulatory Authorities. Part of the API International Training Programme (PIC/S - PDA Q7 Training) is also open to industry participants.

Upcoming meetings and training activities are announced under Training  Calendar.

Training Materials

Expert Circle meeting training materials are available under MaterialsLogin is required.