Validation Practices for the Pharmaceutical Industry

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The BPCS/SIS start-up checklist has been used on many occasions such as unexpected power failures, post-software upgrades check-outs, and planned maintenance outages. The check-list continuously improves as more items are added which further ensure the systems are operating properly after any interrupting event. The Shutdown procedure has also proven beneficial because it documents a complete system shutdown, as well as the most effective partial shutdown of the automation equipment. In the event of an unplanned power outage, the BPCS and SIS are operating from limited UPS battery sources.

A partial shutdown procedure documents the most effective way to conserve energy without losing the process controlling components and providing minimal operator interfaces. On several occasions, this strategy has made the difference between no shutdown at all and a two-hour start-up of the BPCS equipment at a time when this equipment is urgently needed. Previous annual releases of some documents are kept on file as quality records for some specified number of years. Thus, the efforts to validate the automation system enabled one to maintain and improve the system.

* First published in PROCESS India

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