Operation and maintenance of process control systems in the pharmaceuticals industry - Results of the joint committee "Validation of process control systems" of NAMUR and GMA

After successful completion of a prospective GMP compliant validation the automated system including the process control system is being released for production. During its following use in operation the validated status of the system needs to be maintained through qualified operation and technical support. For example, the system's technical documentation has to be updated contemporaneously in case of changes, access regulations have to be implemented and adapted to varying users, backup and archiving of data and software has to be assured, new users must be trained. The execution of these measures is written down in Standard Operation Procedures (SOPs). To assure a reproducible execution regardless of individual working methods of different persons, an appropriate organisation has to make sure that the SOPs are being followed. This also includes documented training on the contents of the SOPs. The article provides a survey of the results of the joint committee "Validation of process control systems" of NAMUR (Standardisation Association for Measurement and Control in Process Industries) and GMA (Society for Measurement and Automatic control of VDI (German Association of Engineers) and VDE (German Association of Electrical Engineers)) on this area of work.