Friday, 5 July 2019

Performance Qualification of Crystal Panel Viewer



Performing the Performance Qualification:
Perform the Operational Qualification as per the check list which contains points defined in the installation requirement that the Crystal Panel Viewer   is supposed to fulfill. In addition, list out control points installed and check the temperature and humidity conditions achieved after the Crystal Panel Viewer has been started after shut down. Note down all the observations in the Operational Qualification Report. Crystal Panel Viewer shall be handed over to Quality Control only after successful completion of Operational Qualification. 
 Record all observations and deviations in the report. In case of deviation prepare a deviation report with justification and get it approved by Head Quality assurance, Head Quality Control.
Check list For Performance Qualification

EQUIPMENT / SYSTEM: CRYSTAL PANEL VIEWER


Test  ( S) Required

Test Description

Acceptance Criteria

Results

Checked by
To check whether the panel is getting on / or not.
Connect the A/c supply to the instrument, switch on the button and observe the panel.
The external white light should be illuminating the lower panel & U.V. light should illuminate the upper chamber.



To check whether the distinguishing fluorescence is observed or not.
Carry out the procedure for any Gram positive organism. And observe same under UV.
It should show clear distinguishing fluorescence which should be compared with the standard chart.


To check whether identification kit is identifying the organism properly or not.
Carry out the test by using suspension of a known standard organism, and observe the result and compare it with the software. 
The identification kit should identify the known organism with high % of identification.



Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.

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