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TEM 270 Installation and Operational Qualification Protocol Template Sample

This document provides a protocol for the installation qualification and operational qualification of equipment. It details tests to verify that the equipment is uniquely identified, installed properly, has documented software, meets safety requirements, and operates as intended to ensure compliance. The objective is to assure the equipment is ready for use in a manner that is validated and adheres to cGMP standards. Deviations from the acceptance criteria are documented in an appendix for resolution.

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Joe Clarke
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© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
1K views

TEM 270 Installation and Operational Qualification Protocol Template Sample

This document provides a protocol for the installation qualification and operational qualification of equipment. It details tests to verify that the equipment is uniquely identified, installed properly, has documented software, meets safety requirements, and operates as intended to ensure compliance. The objective is to assure the equipment is ready for use in a manner that is validated and adheres to cGMP standards. Deviations from the acceptance criteria are documented in an appendix for resolution.

Uploaded by

Joe Clarke
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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TEM-270

Issue date
Installation and Operational Qualification Protocol
(Reference: SOP _____)

Project Name Project Number


Equipment Serial Number
Manufacturer Model Number
Process Line/Location Protocol number

WRITTEN BY: REVIEWED BY:


Name:
Position
Signature:
Date:

APPROVAL TO EXECUTE:
Name:
Position:
Signature:
Date:

PROTOCOL COMPLETION APPROVAL:


Name:
Position:
Signature:
Date:

1 OBJECTIVE
The objective of this protocol is to define the Installation Qualification (IQ) and Operational
Qualification (OQ) requirements and acceptance criteria for the [insert system name and plant
number] which will be located in the [insert area, packaging or manufacturing] at site [insert site
name]. IQ/OQ is required as [insert brief description as to why required, e.g. as it is new
equipment.

Successful completion of this protocol will provide a high degree of assurance that the equipment
has been installed and operates in accordance with the site requirements, specifications and
manufacturers recommendations and is in compliance with cGMP and site policies.

Page 1 of 18
TEM-270
Issue date
Installation and Operational Qualification Protocol
(Reference: SOP _____)

Appendix [Insert Appendix No]


Test 001: Verification of Installed Equipment

1. Objective
The objective of this test is:
1. To verify that equipment is uniquely identified and installed in accordance with site and
manufacturers’ recommendations
2. To verify that equipment is scheduled for preventative maintenance
3. To ensure that the equipment installed is documented for change control / revalidation purposes

2. Procedure
Inspect the installed equipment and record details of all major process equipment as required below.
Verification of installed components may be achieved by visual inspection or approved documentation
/ drawings. If a document or drawing is used it must be referenced.

3. Acceptance Criteria
All equipment must be uniquely identified and installed in accordance with site and manufacturers’
recommendations. All major equipment items should be included for preventative maintenance

Equipment Description Installed Initial & Date


[Insert Equipment Manufacturer
Name. If sub-
systems include Model
one row for each Serial number
sub system]
Plant No
Maintenance log No
[Insert Equipment Manufacturer
Name. If sub-
systems include Model
one row for each Serial number
sub system]
Plant No
Maintenance log No
Comments:

All Acceptance Criteria Met (yes/no): ___________ Initial/Date


Report all deviations/further actions in Appendix [insert Deviation appendix no]
( Deviation ref ________)
Page 5 of 18 Date:
Reviewed By:
TEM-270
Issue date
Installation and Operational Qualification Protocol
(Reference: SOP _____)

Appendix [Insert Appendix No]

Test 005: Verification of Computer System Software

1. Objective
The objective of this test is:
1. To verify that all computer system Operating Software and Application Software integrated with
the system is uniquely identified and installed in accordance with site and manufacturers’
recommendations.
2. To ensure that the software components of the installation are documented for change
control/re-validation purposes.

2. Procedure
Inspect the installed software and record details. Verification of installed components may be
achieved by visual inspection or approved documentation / drawings. If a document or drawing is
used it must be referenced.

3. Acceptance Criteria
1. All software must be uniquely identified and installed in accordance with site and manufacturers’
recommendations.
2. A backup copy of the software must be available.

Software Description Installed Initial & Date


[Insert system Operating Software name
name]
Operating Software version
Application Software name
Application Software version
Application Software Developer
Location of backup
Comments:

All Acceptance Criteria Met (yes/no): ___________ Initial/Date


Report all deviations/further actions in Appendix [insert Deviation appendix no]
( Deviation ref ________)
Page 9 of 18 Date:
Reviewed By:
TEM-270
Issue date
Installation and Operational Qualification Protocol
(Reference: SOP _____)

Appendix [Insert Appendix No]

Test Ref: 010: Verification of Safety

1. Objective
The objective of this test is to verify that EHS are notified that qualification of the system is being
undertaken and a safety audit if required can be performed.

2. Procedure
Contact the EHS representative and determine if a safety audit is required prior to performing any
OQ testing If required enter the estimated completion date for the audit. It is the responsibility of EHS
to complete this test and to ensure that the equipment is safe for operational qualification and for use.

3. Acceptance Criteria
The need for a safety audit has been established prior to OQ and if required a safety audit has been
conducted by EHS and the equipment is deemed suitable for routine use.

Test Test Procedure Actual Initial & Date


#
1 Determine if a Audit required? _________
safety audit is
required
2 Enter the
estimated
completion date
for the safety
audit if required
3 Document if the
system is
considered safe
for operational
qualification
Comments:

All Acceptance Criteria Met (yes/no): ___________ Initial/Date


Report all deviations/further actions in Appendix [insert Deviation appendix no]
( Deviation ref ________)
Page 14 of 18 Date:
Reviewed By:
TEM-270
Issue date
Installation and Operational Qualification Protocol
(Reference: SOP _____)

APPENDIX [Insert Appendix No] – DEVIATION LOG AND REPORT

DEVIATION REPORT NO.:


TEST SCRIPT / TEST PROCEDURE #:
1. DEVIATION DESCRIPTION:

Initial / Date_______
Circle Critical Non- Circle Yes No
Deviation # COMMITMENT #
Classification Deviation Critical Change Change #
________ ___________
Deviation Required ________

2. RESOLUTION (attach any re-test results to this sheet):

Resolution Completed & Deviation Resolved: (yes/no) ___ Initial / Date_______

3. JUSTIFICATION FOR ACCEPTANCE OF DEVIATION:

Justification Completed & Deviation Accepted: (yes/no) ___ Initial / Date_______


Print/Type Name Signature Date
Approved By: (System Owner)
Approved By: (Validation)
Approved By: (Quality
Assurance)

Page 18 of 18

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