OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE

OPERATIONAL QUALIFICATIONS OF COMPRESSION MACHINE

TABLE OF CONTENT

• Purpose
• Scope
• Responsibilities
• Procedure
• Operational qualification tests
  • Main Panel / Control Panel Testing
  • Power & Communication Failure Recovery Verification
  • Safety Features Verification
  • Variable 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 procedure to be used during qualification of B4 Type 35 Station. “B” Tooling Tab, Machine, its accessories and to define the specification of the system in order to:

• ensure that the equipment meets the Operational/Design limits as per user requirements.
• ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices.

• SCOPE

This procedure applies to the Operational qualification of B4 Type 35 Station. “B” Tooling Tab, Machine and its accessories to be installed at Pharmaceutical company.

• RESPONSIBILITIES
  • It is the responsibility of the Manufacturer to prepare the Operational qualification protocol.
  • 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 B4 Type 35 Station. “B” Tooling Tab, 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.

 Main Panel / Control Panel Testing

5.1.1    Purpose –

To verify that the response of the equipment at the input from various Pushbutton / Switches on control or main panel.

• Test equipment –

None Required.

• Procedure –
  • Give inputs from various Push buttons & Switches on Control Panel / Main Panel.

• 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

 Conclusion: 

PASS                                      FAIL

Checked by:                                                                                       Verified by:

Date:                                                                                                    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 in automatic mode or 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. Record whether the equipment starts normally, 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 shall restart normally, with no problems or adverse conditions.

• Power and Communication Failure Recovery test results

 Conclusion: 

PASS                                      FAIL

Checked by:                                                                                       Verified by:

Date:                                                                                                    Date:

• Safety Feature Verification           

• Purpose –

To avoid damage to the operator or property while operating the equipment.

• Test equipment –

None Required.

• Procedure –
  • Operate the equipment as mentioned in the tabular column.

• Acceptance Criteria –
  • The equipment shall respond as mentioned in the target column of the table given below.

• Failsafe Results –

 Conclusion: 

PASS                                      FAIL

Checked by:                                                                                       Verified by:

Date:                                                                                                   Date:

• Variable RPM verification
  • Purpose –

To check the RPM of turret as per RPM observe at the counter screen.

• Test equipment –

Digital Tachometer.

• Procedure –
  • Start the equipment as per operational manual.
  • observe the RPM of the turret with digital tachometer. Repeat process for three times.
  • Rotate the rotary knob to anticlockwise and clockwise and observe the RPM for both side rotations. Repeat process for three times.

• Acceptance Criteria –
  • For step 5.4.3.2 the RPM on screen and digital tachometer shall not vary more than 5%.
  • For step 5.4.3.2 on anticlockwise rotation of the rotary knob turret RPM shall decrease and on clockwise rotation turret RPM shall increase. Both side average RPM on screen and digital tachometer shall not vary more than 5%. 

• Variable RPM verification test results

Note:

1. a) Enter the no of rotation for ‘1’ minutes in the trial –1, 2 & 3 columns.
2. b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3 

Conclusion:

PASS                                      FAIL

Checked by:                                                                                  Verified by:

Date:                                                                    Date

• Operational Qualification Tests Status

The table below lists the tests performed and related results.

• LIST OF STANDARD OPERATING PROCEDURES 

 Data Analysis, Summary of OQ & Recommendations

• AMENDMENT RECORD

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

• CONCLUSION

Prepared by                                Reviewed By                         Approved by

NORFLOXACIN & LOPERAMIDE CAPSULE