PIC/S - Recommended model for Risk-Based inspection planning in the GMP environment

The PIC/S (The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) have issued a guidance document (reference PI 037-1) on a Quality Risk

Management tool that may be used by Inspectorates when planning the frequency and scope of GMP.

It is based on the following documents:

• ICH Q9 - Quality Risk Management
• Annex 20 to the PIC/S GMP Guide
• The EMA Compilations of Community Procedures Document No.
• INS/GMP/499073/2006 – A Model for risk-based planning for inspections of Pharmaceutical Manufacturers
• ICH Q10 – Pharmaceutical Quality Systems

The PIC/S document can be found at: PIC/S

PIC/S' mission is "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."

This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organisations.

Posted by Tim Sandle