PIC/s the Pharmaceutical Inspection Cooperation Scheme (PIC/s) the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel. The PIC Scheme purpose pertains to improving public health by
- pursuing and strengthening the cooperation established between the participating authorities in the field of inspection for promoting quality assurance of inspections,
- providing the framework for all necessary exchange of information and experience,
- coordinating mutual training for inspectors and for other technical experts in related fields,
- continuing common efforts towards the improvement and harmonization of technical standards and procedures regarding the inspection of the manufacture of medicinal products and the testing of medicinal products by official control laboratories,
- continuing common efforts for the development, harmonization and maintenance of Good Manufacturing Practices (GMPs), and
- extending the cooperation to other competent authorities with for the purpose of global harmonization.
Members include Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Portugal, Romania, Singapore, Slavac Republic, Spain, Sweden, Switzerland and the United Kingdom.
Guide to Good Manufacturing Practices-The PIC/S Guide to Good Manufacturing Practices is the basis for GMP inspections. In particular its Annex 11, ‘Computerised Systems’ is used when
inspecting such systems. The purpose of this document is to provide recommendations and background
information concerning computerised systems that will be of assistance to inspectors for training purposes and during the inspection of computerised systems. The purpose of this document is to provide recommendations and background information concerning computerized systems that will assist inspectors for training purposes and during the inspection of computerized systems in Europe.
