Operational Qualification Report - Gmpsop
[Pages:1]Operational Qualification Report
(Ref.VAL-005)
Operational Qualification Report
(Ref.VAL-005)
Project Name Equipment Manufacturer Process Line/Location
Project Number Serial Number Model Number Protocol number
TEM-030 Issue date
Table of Content
PROCESS DESCRIPTION ...........................................................................................................................1 OBJECTIVE .................................................................................................................................................1 INSTRUMENTATION/CALIBRATION ..........................................................................................................2 TEST FUNCTIONS PERFORMED IN THE OPERATIONAL QUALIFICATION PHASE AND OVERALL RESULTS OBTAINED:..................................................................................................................................................2 ADDITIONAL VALIDATION REQUIREMENTS ............................................................................................2 OVERALL CONCLUSION............................................................................................................................3 PERFORMANCE QUALIFICATION PROGRAM ..........................................................................................3
Approval Of The Completed Operational Qualification Report
Department Project Co-ordinator Validation Manager Quality Assurance Manager Operations Manager Production Manager
Name
Signature
Date
Approval signifies provisional approval of the equipment / system for production use.
Process Description
(Describe the process which is due to Operational Qualification)
Objective
The objective of the Operations Qualification is to perform a series of tests to determine that the operation of the equipment/process conforms to the specifications.
The tests conducted are outlined in Part 4. of this report. Each individual test function listed has the acceptance criteria specified.
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