Implementing the methodology
The PIC/S example of methodology provides pharmaceutical manufacturers with the means, including training tools and a starter
kit, to implement quality risk management. The methodology relies on an interactive database that is accessible to industry.
This service, expected to be available soon, will be hosted and maintained on an independent platform that brings together
industry, professional associations, and other pharmaceutical manufacturing partners. Drug manufacturers will be able to
voluntarily integrate the system on a customer-supplier basis (see Figure 1).
Figure 1: Diagram of a sample operation in service. CAPA is corrective and preventive action. QRM is quality risk management.
GMP is good manufacturing practice. (FIGURE 1 IS COURTESY OF THE AUTHORS)
The platform will make available the assistance necessary to implement the method, guarantee confidentiality, and use the
information supplied exclusively for implementing the risk-management methodology.
The informal PIC/S working group has performed beta-tests on the proposed methodology. The methodology will, however, need
to be placed under change-control management to achieve continuous improvement.
PIC/S will finalize and implement the example of methodology, possibly by the end of 2010.
Read more about the Pharmaceutical Inspection Cooperation Scheme at
Lionel Viornery is an inspector and head of the starting materials inspection unit at the French Health Products Safety Agency (Afssaps),
143/147, bd Anatole, Saint Denis cedex, 93285, France, firstname.lastname@example.org
. Philippe Legoff is managing director of H&LG Consultants, Biolleyre 5, CH-1066 Epalinges, Switzerland, email@example.com