Sunday, October 18, 2009

Handling of OOT for FDA Inspections !!

Concerns to GMPs are generally linked to the fear of FDA Auditors. As if the systems and procedures of organization are designed for the inspectors rather then for the internal improvements. 

First, there is no separate point of view of FDA from cGMP / system requirements. A self justified system with appropriate scientific rational must be acceptable to anyone, including FDA inspectors. 

The OOT procedure must have : 

(a) OOT identifying mechanism 
(b) OOT addressing mechanism (or action / alert program), and 
(c) Link to CAPA. 

The risk assessment study of process highlights the parameters where OOT must be identified. An appropriate study of available data helps in laying the limits for alert and / or action points (which are nothing but OOT action limits). 

The action plan for OOT (alert / action) is different for different parameters. 

The action plan may be linked to CAPA program so that (i) root cause of OOT is identified and (ii) repetition of OOT is eliminated.

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