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OPERATIONAL QUALIFICATION PROTOCOL FOR COATING MACHINE

 TABLE OF CONTENT

  • Purpose
  • Scope
  • Responsibilities
  • Procedure
  • Operational qualification tests
    • Main Panel / Control Panel Testing
    • Power & Communication Failure Recovery Verification
    • Variable RPM verification
    • Operational Qualification Test Status
  • List of Standard Operating Procedures
  • Data Analysis, Summary of OQ & Recommendations
  • Amendment record
  • Conclusion
  • PURPOSE

To describe the Operational Qualification procedure to be used during qualification of Coating Machine and to define the specification of the system in order to:

  • Ensure that the equipment meets the Operational/Design limits.
  • Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices.
  • SCOPE

This procedure applies to the Operational qualification of Coating Machine to be installed at Pharmaceutical Company.

  • RESPONSIBILITIES
    • It is the responsibility of the Validation Team to prepare and check the operation qualifications protocol.
    • It is the responsibility of the Quality Assurance to approve the operation qualification protocol.
    • It is the responsibility of the Validation Team to perform and check all the specifications verification checks with respect to operation qualifications protocol and compiling data.
    • It is the responsibility of the Quality Assurance to approve the operation qualification.
  • PROCEDURE

The following requirement / practices apply to Coating Machine 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
Main Panel/Control Panel Testing
Power & Communication Failure Recovery Verification
Variable RPM verification
Operational Qualification Test Status

  

  • 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

Main Panels main switch switched ON.  Machine ON indicator shall glow
Main motor START button pressed Main motor shall start and pan shall start rotating
Blower motor START button pressed Blower motor shall start running
Main motor Stop Button is pressed Pan shall stops rotating
Blower motor STOP button pressed Blower motor shall stop running

 

  • 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; check operation and note any adverse condition.
  • Acceptance criteria –
    • The equipment stops in a safe and secure condition.
    • The equipment should not start of its own after the power is restored without user permission.
    • The equipment can be restarted with NO problems or adverse conditions.
  • Power and Communication Failure Recovery test results
Test Results Meets Test

(Yes / No)

Test Done by Date
Main Power Shut Down Equipments Stops in a secure and safe condition
Main Power Restored Equipments is not starting of its own without user permission
Equipment can be restored with no problem or adverse condition

 

  • Variable RPM verification test 
  • Purpose –

To check the equipment rotation by moving the main motor forward and backward.

  • Test equipment –

Digital Tachometer Required.

  • Procedure –
    • Start the equipment.
    • Measure the RPM using digital tachometer and note down the RPM in the table.
    • Change the position of main motor by rotating the wheel in clockwise and anticlockwise direction as mentioned in the table and repeat the above procedure.
  • Acceptance Criteria –
    • The equipment will respond as mentioned in the target column of the table given below.
  • Variable RPM verification test results
Test Results Meets Test

(Yes / No)

Test Done by Date
Main motor switched ON and check the RPM with digital tachometer Pan shall start rotating
Turn OFF the main motor Pan shall stop rotating
Rotate the wheel in clockwise direction Main motor shall move forward.
Main motor switched ON and check the RPM with digital tachometer Pan shall start rotating. The RPM shall increase
Turn OFF the main motor Pan shall stop rotating
Rotate the wheel in anticlockwise direction Main motor shall move backward.
Main motor switched ON and check the RPM with digital tachometer Pan shall start rotating. The RPM shall decrease

 

  • 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
Main/Control Panel Testing
Power & Communication Failure Recovery Verification
Variable RPM verification test
  •  LIST OF STANDARD OPERATING PROCEDURES 
Sr.  No. Description SOP No Verified By Date
1 Operating Procedure of Coating Machine
2 Cleaning Procedure of Coating Machine
3 Preventive maintenance of Coating Machine

  

  • Data Analysis, Summary of OQ AND RECOMMENDATIONS
  • AMENDMENT RECORD
Sr. No. Item Name Remarks Signature and Date

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

  • CONCLUSION

 

 

 

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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