Process Control System
Basic Guidelines for Process Control System Validation
The supplier normally writes the FS or control narrative according to the process design report. It is important that the end-user reviews and approves FS to authorize the detailed design, development and building of the system.
In practice, FS is continually updated and refined as the detailed design process develops. These two documents normally require a significant amount of time to interface with the end-user to create, develop and finalize. Both documents are GMPcontrolled and should be compliant with all GMP requirements. In case of failure to comply, one could be issued a warning letter from USFDA for non-compliance to cGMP requirements.
Why cGMP Compliance is Vital for Pharmaceutical Companies
Compliance to cGMP is a crucial and mandatory requirement in the pharmaceutical industry, as companies are constantly under the scrutiny of FDA. Hence, violations by any company will hamper its prospects and even harm its reputation.