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.

Main Panel/Control Panel Testing

Power & Communication Failure Recovery Verification

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 buttons / Switches on the 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 a dry run of the equipment to ensure that all controlling parameters &functions are reproducible.

Test Results

Input	Target
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

 

 

 

 

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 the system starts running once the power is restored

If the system is not starting on its own, restart the equipment and note any adverse conditions.

Acceptance criteria –

The equipment shall stop in safe and secure condition.

The equipment should not start on its own after the power is restored without user permission

The equipment can be restarted with no problems or adverse conditions observed.

Power and Communication Failure Recovery test results

Test	Results
Main Power Shut Down	Equipment stops in a safe and secure condition.
Main Power Restored	Equipment is not starting on its own without user permission
	Equipment can be restarted with NO problems or adverse conditions observed

 

 

 

 

Main Operational Parameter. (Eg. RPM Verification)           

Purpose –

To verify the RPM of the blade roller.

Test equipment –

Digital Tachometer.

Procedure –

Start the equipment as per the user manual.

observe the rotation of the equipment for ‘1’ minute (Note down the value in the respective trial column) using a tachometer.

Continue the procedure no: 5.3.3.2 for total ‘3’ times.

Acceptance Criteria –

The average RPM of the blade roller should match with the specified RPM.

RPM verification test results

Acceptance Criteria	Trial-1No of Revolution	Trial-2No of Revolution	Trial-3No of Revolution	Average RPM
20±1 rpm

 

 

Note:   Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3

Operational Qualification Tests Status

The table below lists the tests performed and related results.

Critical Feature 

Main/Control Panel Testing
Power & Communication Failure Recovery Verification
Main Operational Parameter. (Eg. RPM Verification)

LIST OF STANDARD OPERATING PROCEDURES 

Operating Procedure of Name of the Equipment
Cleaning Procedure of Name of the Equipment
Preventive maintenance of the Name of the Equipment

Data Analysis, Summary of OQ & Recommendations:

Note: Any changes made in the system must be recorded in this sheet.

CONCLUSION

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