TEMPLATE FOR OPERATIONAL QUALIFICATION PROTOCOL
TABLE OF CONTENT
- Purpose
- Scope
- Responsibilities
- Procedure
- Operational qualification tests
- Main Panel / Control Panel Testing
- Power & Communication Failure Recovery Verification
- Main Operational Parameter. (Eg. RPM Verification)
- Operational Qualification Tests Status
- List of Standard Operating Procedures
- Data Analysis, Summary of OQ & Recommendations
- Amendment record
- Conclusion
- PURPOSE
To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to:
- ensure that the equipment meets the Operational/Design limits as per user requirements: Document number.
- ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices.
- SCOPE
The scope of this document applies to the operational qualification of Name of the Equipment to be installed at pharmaceutical Company Name with Location.
- RESPONSIBILITIES:
- It is the responsibility of the Manufacturer to prepare the Operational qualification protocol and identify the test parameters to be studied for qualifying the Name of the Equipment
- It is the responsibility of the client to check and approve the Operational qualification protocol.
- It is the responsibility of the Manufacturer to perform all the tests with respect to Operational qualification and compiling data in co-ordination with client.
- PROCEDURE
The following requirement / practices apply to Name of the Equipment Operational Qualification activities:
- To verify the components design parameters.
- Review the preventive maintenance procedures, cleaning procedures and general operational procedure to ensure that they are comprehensive for reliable performance of the equipment.
- OPERATIONAL QUALIFICATION TESTS
The table below lists the tests to be performed as part of the Operational Qualification phase.
| TEST NUMBER | CRITICAL FEATURE |
| 5.1 | Main Panel/Control Panel Testing |
| 5.2 | Power & Communication Failure Recovery Verification |
| 5.3 | Main Operational Parameter. (Eg. RPM Verification) |
- Main Panel / Control Panel Testing.
- Purpose –
To verify that the response of the equipment at the input from various
Push button / Switches on control or main panel is as per the system design.
- Test equipment –
None Required.
- Procedure –
- Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
- Acceptance Criteria –
- The equipment will respond as mentioned in the target column of the table given below.
- Take dry run of the equipment to ensure that all controlling parameters &functions are reproducible.
- Test Results
|
Input |
Target |
Actual |
Test Done by |
Date |
| Control OFF/ON switch on control panel switched ‘ON’ | Control ON indicating lamp will glow. | |||
| ‘ON’ push button is pressed. | Machine starts working | |||
| ‘OFF’ push button is pressed. | Machine stops working |
Conclusion:
PASS FAIL
Checked by/Date: Verified by/Date:
- Power & Communication Failure Recovery Verification
- Rationale –
To verify that in the event of a power loss or communications failure, the equipment will stop in safe condition.
- Test equipment –
None Required.
- Procedure for Power and Communication Failure Recovery test –
- Operate the equipment as directed in the User Manual.
- While the equipment is operating, shut down the power to the main control panel. Record if the equipment stops in a safe and secure condition.
- Wait for 5 minutes then restore power to the equipment.
- Check whether system is start running once the power is restored
- The system is not starting of its own, restart the equipment and note any adverse condition.
- Acceptance criteria –
- At step 5.2.3.2 the equipment shall stop in safe and secure condition.
- At step 5.2.3.4 the equipment should not start of its own after the power is restored without user permission
- At step 5.2.3.5 the equipment can be restarted with no problems or adverse conditions observed.
- Power and Communication Failure Recovery test results
| Test | Results | Meets Test
(Yes / No) |
Test Done by | Date |
| Main Power Shut Down | Equipment stops in a safe and secure condition. | |||
|
Main Power Restored |
Equipment is not starting of its own without user permission | |||
| Equipment can be restarted with NO problems or adverse conditions observed |
|
Conclusion:
PASS FAIL
Checked by/Date: Verified by/Date:
- Main Operational Parameter. (Eg. RPM Verification)
- Purpose –
To verify the RPM of blade roller.
- Test equipment –
Digital Tachometer.
- Procedure –
- Start the equipment as per user manual.
- observe the rotation of the equipment for ‘1’ minute (Note down the value in respective trial column) using tachometer.
- Continue the procedure no: 5.3.3.2 for totally ‘3’ times.
- Acceptance Criteria –
- The average RPM of the blade roller should match with the specified RPM.
- RPM verification test results
|
Acceptance Criteria |
Trial-1 No of Revolution |
Trial-2 No of Revolution |
Trial-3 No of Revolution |
Average RPM
|
Test Done by | Date |
|
20±1 rpm
|
Note: Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
Conclusion:
PASS FAIL
Checked by/Date: Verified by/Date:
- Operational Qualification Tests Status
The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass / Fail | Deviation Found | ||
| Pass | Fail | Yes | No | ||
| 5.1 | Main/Control Panel Testing | ||||
| 5.2 | Power & Communication Failure Recovery Verification | ||||
| 5.3 | Main Operational Parameter. (Eg. RPM Verification) | ||||
- LIST OF STANDARD OPERATING PROCEDURES
| S.No | Description | SOP No | Verified By | Date |
| 1 | Operating Procedure of Name of the Equipment | |||
| 2 | Cleaning Procedure of Name of the Equipment | |||
| 3 | Preventive maintenance of Name of the Equipment |
- Data Analysis, Summary of OQ & Recommendations:
- AMENDMENT RECORD
S.No. |
Item Name |
Remarks |
Signature and Date |
Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
Prepared by Reviewed By Approved by
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