TEMPLATE FOR OPERATIONAL QUALIFICATION PROTOCOL

           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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