Operational qualification of equipment in Pharma

- Verifies that the equipment operates consistently within established limits and tolerances over the defined operating ranges. Studies on critical variable to include conditions encompassing upper and lower operating limits and circumstances (i.e.“worst case conditions”)

- It provides the document evidence that the equipment is operating within the pre defined range.  

-During the operational qualification Critical operating parameters should be identified.

-After successful installation of the equipment Operational qualification shall be performed.   

    -OQ protocol shall include following check points:

          - Test of operation parameters and its range (E.g Pressure range, Temperature   range, RPM of the centrifuge)

          - Testing of Alarm 

          - Check the functionality of the equipment 

          -  If any software are there then challenge of software

     -Critical operating parameters shall be identified during Operational qualification.

-Training of operators for the systems, utilities and equipment should be provided and training records maintained during operation qualification stage.

-Systems, utilities and equipment, as appropriate should be released for PQ or routine use after completion of OQ.

-The results of the OQ should be recorded in the conclusion of the report, before    PQ is started.

- SOPs for the operating of equipment shall be prepared in this stage of the qualification as personnel can follow that SOP.

     -The results for the verification of operation shall be recorded in to the reports.