TEM-225

Issue date
Validation Report-Combined OQ/PQ
(Reference SOP: _______)

Project: Project No:

Equipment Description: Serial No:
Manufacturer: Model No: Equipment
No:
Location: Protocol:

Section 1: OPERATIONAL QUALIFICATION REPORT

Approval signifies provisional approval of the equipment / system for production use.

APPROVAL OF THE COMPLETED OPERATIONAL QUALIFICATION

POSITION NAME SIGNATURE DATE

Project Co-ordinator/Manager

Validation Manager

Quality Assurance Manager

Operations Manager

Production Manager

Note: All signatures must be signed in the above table before commencement of Performance
Qualification tests.

Section 2: VALIDATION REPORT

Approval signifies full approval of the equipment / system for production use.

APPROVAL OF THE VALIDATION PROGRAM

POSITION NAME SIGNATURE DATE

Project Co-ordinator/Manager

Validation Manager

Quality Assurance Manager

Operations Manager

Production Manager

Prepared By: Date: Revision No:

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 TEM-225
Issue date
Validation Report-Combined OQ/PQ
(Reference SOP: _______)

Tabulate and review all data referenced above. Form a conclusion as to the acceptability of the overall
program based on the acceptance criteria specified above.
Conclusion:

10. REVALIDATION PROGRAM

Revalidation of this equipment / system is required:
· When the findings of in-process and quality control tests indicate the need.
· Routinely:

Tests Required Frequency

Completed Validation Report :

SECTION 2 Position Signature Date

Documented by:

Checked by:
(Project Coordinator /
Manager)

Prepared By: Date: Revision No:

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