Quality Risk Management

The PIC/S Expert Circle on Quality Risk Management (QRM) was established in 2007. It has been active in developing models for QRM systems for Inspectorates as well as guidance on the assessment of QRM implementation in industry. This Expert Circle has also been very involved in developing training for inspectors (i) to enable them to inspect QRM systems in a harmonised manner and (ii) to enable them to effectively inspect QRM activities on site at an advanced level and use the PIC/S Recommendation in relation to risk-based GMP inspection planning.

PIC/S QRM Advanced Training Course, hosted by Japan / PMDA, Tokyo (Japan), 2014


Chairperson of the PIC/S Expert Circle on QRM, Karmin Saadat (Austria / AGES)

Key Features

First PIC/S Expert Circle on QRM (2007-2011)
 

The goals of the First Expert Circle on QRM were to:

  • develop a training programme for Inspectors to enable them to inspect QRM systems in a harmonised manner. The training was limited to principles, tools and examples related to the implementation of QRM in industry;
  • develop models for QRM systems for Inspectorates. This was limited initially to the planning, the conduct, the follow-up of inspection and quality defect management;
  • develop guidance on the assessment of QRM implementation in industry;
  • develop a communication system between PIC/S Participating Authorities to facilitate the application of QRM;
  • update and upgrade the Site Master File to take into account QRM.

Second PIC/S Expert Circle on QRM (as from 2012)

The overall goal of the Second Expert Circle on QRM - further to the completion of the mandate of the first Expert Circle on QRM - is the development and provision of advanced training courses for GMP Inspectors. These courses enable Inspectors to effectively inspect Quality Risk Management activities on site at an advanced level and effectively use the 2011 PIC/S Recommendation in relation to risk-based GMP inspection planning (PI 037).
 

Guidance Documents

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

Advanced QRM Training 

The advanced QRM training programme is threefold and covers:
 
  • How to critically inspect the implementation and use of Quality Risk Management during regulatory inspections.
  • How to critically inspect at an advanced level Risk Assessments at manufacturing sites.
  • How to effectively use the Risk-based GMP Inspection planning tool that was developed by the first Expert Circle.

Past Advanced QRM Training

London | UK 2016
Los Angeles | USA 2015
Tokyo | Japan 2014

 

Past Expert Circle Meetings

Budapest | Hungary 2013
Vienna | Austria 2012
Warsaw | Poland 2010
Saint-Denis | France 2009
Gzira | Malta 2008
London | United Kingdom 2008
Paris | France 2007

Upcoming Expert Circle Meetings and Advanced Training

Expert Circle meetings and training activities are only open to Inspectors from PIC/S Participating Authorities, (Pre-)Applicants, Partners and Non-Member National Medicines Regulatory Authorities. The events are not open to Industry.

Upcoming meetings and training activities are announced under Calendar.

Training Materials

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