SOP for Operational Qualification of Capsule Printing Machine
- PURPOSE:
- To describe the Operational Qualification of Capsule Printing Machine its accessories and to define the specification of the system in order to:
- ensure that the machine meets the Operational / Design limits as per user requirements
- ensure that the machine will be operationally qualified in accordance with current Good Manufacturing Practices.
- SCOPE:
- The scope of this document applies to the operational qualification Capsule Printing Machine
- RESPONSIBILITIES:
- 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.
- It is the responsibility of the client to check and approve the Operational Qualification.
- PROCEDURE:
- The following requirement / practices apply to Capsule Printing 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 machine.
- 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 |
| 5.2 | Power & Communication Failure Recovery Verification |
| 5.3 | Operational Qualification Tests Status |
- Main Panel / Control Panel.
- Purpose – To verify that the response of the machine at the input from various Pushbutton / Switches on control or main panel is as per the system design.
- Test machine – None Required.
- Procedure – Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
- Acceptance Criteria – The machine shall respond as mentioned in the target column of the table given below.
- Test Results
| Input | Target | Actual | Test Done by | Date |
| Press START Switch | Machine shall start running | |||
| Press STOP switch | Machine shall stop running | |||
| Rotate Auto/Jog Rotary Switch to Jog position and press Jog Push Button . | Machine shall start running till Jog Push Button is pressed | |||
| Rotate Auto/Jog Rotary Switch to Auto position and press Jog Push Button. | Machine shall not start running | |||
| Press START Switch | Machine shall start running | |||
| Rotate Speed Regulator Knob in clockwise direction | Feed Disc speed shall increase | |||
| Rotate Speed Regulator Knob in anticlockwise direction | Feed Disc speed shall decrease |
Conclusion:
PASS FAIL
Verified By: _______________________ Date: ______________
Checked By: ________________________ Date: ______________
- Power & Communication Failure Recovery Verification
- Rationale – To verify that in the event of a power loss or communications failure, the machine will stop in safe condition.
- Test machine – None Required.
- Procedure for Power and Communication Failure Recovery test – Operate the machine in automatic mode or as directed in the User Manual. While the machine is operating, shut down the power to the main control panel. Record if the machine stops in a safe and secure condition. Wait for 5 minutes then restore power to the machine. Check whether system is start running once the power is restored. The system is not starting of its own, restart the machine.
- Acceptance criteria – At step 5.2.3.2 the machine stops in a safe and secure condition. At step 5.2.3.4 the machine should not start of its own after the power is restored without user permission At step 5.2.3.5, the machine can be restarted with NO problems.
- Power and Communication Failure Recovery test results
| Test | Results | Meets Test
(Yes / No) |
Test Done by | Date |
| Main Power Shut Down | Machine shall stop in a safe and secure condition. | |||
| Main Power Restored | Machine shall not start on its own without user permission | |||
| Machine shall be restarted with NO problems. |
|
|||
| Press Emergency Stop | Machine shall stop in a safe and secure condition. | |||
| Release Emergency Stop | Machine shall not start on its own without user permission | |||
| Machine shall be restarted with NO problems |
- Conclusion:
- PASS FAIL
- Verified By: _______________________ Date: ______________
- Checked By: ________________________ Date: ______________
- RPM verification
- Purpose – To verify the RPM stirrer.
- Test equipment – Tachometer required.
- Procedure – Start the equipment as per user manual. Set the RPM and 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 stirrer should match with the set RPM.
- RPM verification test results
| Set RPM | Trial-1
No of Revolution |
Trial-2
No of Revolution |
Trial-3
No of Revolution |
Average RPM
|
Test Done by | Date |
- Note:
- a) Enter the no of rotation for ‘1’ minutes in the trial –1, 2 & 3 columns.
- b) Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
- Conclusions
- 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 | |
| Yes | No | ||||
| 5.1 | Main/Control Panel | ||||
| 5.2 | Power & Communication Failure Recovery Verification | ||||
| 5.3 | RPM Verification | ||||
- LIST OF STANDARD OPERATING PROCEDURES
| Sr. No | Description | SOP No | Verified By | Date |
| 1 | Operating Procedure of Capsule Printing Machine | |||
| 2 | Cleaning Procedure of Capsule Printing Machine | |||
| 3 | Preventive maintenance of Capsule Printing Machine |
- DATA ANALYSIS , SUMMARY OF OQ & RECOMMENDATIONS
- AMENDMENT RECORD
| Sr. No. | Item Name | Remarks | Signature & 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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