On the topic of computer validation, a great number of regulations and guidelines were published during the past years. The most recent documents were published by the American FDA on “Electronic Records/Electronic Signatures” and by the pharmaceutical industry: “GAMP 4”. Just as the FDA provides its inspectors with interpretation guidelines in the form of the “Guides to Inspection”, PIC/S (Pharmaceutical Inspection Co-operation Scheme) also furnishes its members’ inspectors with such guidelines, i.e. the PIC/S Guidances. The interpretations are based on the EU GMP Guide and, particularly, on Annex 11 “Computerised Systems”.
In September 2003, the PIC/S Guidance “Good Practices for computerised Systems in Regulated ‘GXP’ Environments” came into force, which is primarily directed at the authorities’ inspectors, but which also points out the state of the art and knowledge to the pharmaceutical industry and its suppliers. It is perfectly clear that the authors of this guidance did not intend to reinvent the wheel. Their intention was to set out in detail the state of the art and knowledge by referencing current documents, e.g. GAMP 4 and 21 CFR Part 11.
The Guidance is divided into the 3 parts:
- Preamble
- Implementation of Systems
- System Operations / Inspection / References
Above all part 3 is very interesting because it contains checklists and aide-memoires that can be used by inspectors during inspections. Within the framework of the Computer Validation Conference 2004, the PIC/S Guidance and its interpretations by representatives of the German supervisory authorities were the definitive documents. Members of the German expert group “computerised systems” demonstrated the applicability of this document to the most diverse partial aspects of the validation of computerised systems. Representatives from the pharmaceutical industry commented on this guidance and its applicability from an industry viewpoint. Here, it became clear that above all the topics risk analysis/risk management or change management have meanwhile assumed a pivotal role in the regulations, but also in daily practice.
While the broad outlines of the correct validation of computerised systems have in the meantime become generally known in the industry and are also observed (especially GAMP 4 should be mentioned here as a standard), a great number of partial aspects still gives rise to uncertainty as to their implementation. The conference also included a panel discussion, during which a variety of such questions was debated. In the following, we would therefore like to repeat some of the questions and the respective answers given by the representatives from authorities and the industry.
