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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