The PIC (Pharmaceutical Inspection Convention) was founded in 1970 between the EFTA states as a treaty for the mutual recognition of inspections of the manufacture of pharmaceutical products. Little by little, further European and non-European countries entered into this agreement. Owing to the European interpretation of the law, from the beginning of the 90s, it has not been possible any more for member states of the European Union to become members of this convention. For this reason, the PIC was developed further to become the PIC/S in 1995 (Pharmaceutical Inspection Co-operation Scheme). The PIC/S is no longer an agreement between states, but a less formal and more flexible co-operation between inspection authorities for the purpose of information and experience exchange. The main basis for official inspections is the EU GMP Guide, and for the field of “computerised systems,” Annex 11. Both of them use basically the same wording as the respective PIC documents. With the “Good Practice Guidance,” the PIC/S wants to provide the inspectors with background information and recommendations for the inspection of computerised systems. It is meant to reflect the state of the art and knowledge and should not hinder technological progress either. This guidance is not mandatory for the pharmaceutical industry; however, fulfilling these requirement is generally considered to be sufficient. It is to be expected that, in the future, European inspectors will keep very close to the requirements of this guidance as to questions concerning the inspection of computerised systems.
