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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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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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