Validation of PROFIBUS Systems
The focus is on pharmaceutical applications that are required to adhere to Current Good Manufacturing Practice (cGMP) in meeting the regulations of national authorities as inspected and enforced by them. For example the Food and Drug Administration (FDA) with the Code of Federal Regulations (CFRs) of the USA.
This guideline addresses each ”phase” of Validation as it applies to new applications with PROFIBUS based automation systems from PI members, including the process management functions. Within the scope of validation for an entire, automated production plant / process, the PROFIBUS based automation systems is only a component part. This guideline will assist the reader in understanding and generating the procedures, documentation and information necessary to qualify a PROFIBUS based automation system.
This guideline does not include the qualification of the controlled function (e.g., process equipment) and associated operating procedures, or other systems not provided by PROFIBUS devices.
This guideline represents the PROFIBUS qualification for supporting the validation. It offers arguments for the use of PROFIBUS in systems requiring validation based on GAMP 4, NAMUR and FDA requirements. In addition, it describes standard operating procedures (SOP) to support the configuration, It can also be used for training purposes.
Order No.: 2.292