Combining Equipment and Process Validation


FDA guidance states to complete equipment/computer system validation ahead of starting process validation. Is this an absolute regulatory requirement however?
And if not what if any are the disadvantages of combining equipment/computer system validation and process validation ie. drafting an OQ which checks the functions and operation of the equipment/computer system and also completes tests normally found in a Process OQ such as defining and assessing the capability of the system (process step) over a number of test batches at the process limits?

Finally, is a cumulative sequenced validation of each process step equivalent to a full line process validation?

This is an Excllent question.
We all know that new ASTM E-2500 & FDA validation guideline is in place. Most of pharma and Bio-Pharm folks are following ASTM guideline as it is risk based. Based on this new guideline both activities of Validation for Equipments and Processes cannot be comined that easily unless you have a robust mechanism.
What is that robestness which drives both?
-Design Qualification and Enhanced Design Review
-The most important one is CCCP which evolved from HACCP.This is risk based again

No company will combine the both activities unless these highlighted factors are in place, control and scientifically driven.