SOP for Operational qualification protocol of Blister Packing Machine (BQS)

March 5, 2017February 3, 2023 Pharma Editor

SOP for Operational qualification protocol of Blister Packing Machine (BQS)

PURPOSE
To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to define the specification of the sytem 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 Good Manufacturing Practices

SCOPE
This procedure applies to the Operational qualification of Blister Packing Machine (BQS).

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 Blister Packing Machine (BQS) Operationally.
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 PAM-PAC Blister Packing Machine (BQS), 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
	Testing of Programmable Logic Controller’s Processor
	Verification of Man Machine Interface Screens – MMI
	Power & Emergency Failure Recovery Verification
	Emergency Operation Verification
	Verification of Alarms

Testing of Programmable Logic Controller’s Processor
Rationale – To verify the normal operation of PLC Processor by observing the processor module’s LED status indicator after turning on the PLC.

Test Equipment – None required.

Procedure – Turn panel power to ON position – Turn PLC power to ON position – Check that PLC Processor is in RUN Mode – Document the following indicators located on PLC front panel
Acceptance Criteria – The processor should function as specified in the verification table.

Verification results –

Indicator	Specified	Actual	Meet the Spec. (Yes / No)	Initial / Date
Power LED	LED on when PLC power applied
Run LED	LED on when PLC is in RUN Mode
Error LED	LED on when PLC is in error
Battery LED	LED on when battery is low
If actual result is not like expected result turn power to panel “OFF” and notify to engineer. Document any discrepancies on the operational qualification deviation report.

Conclusions / Comments:PASS FAIL
Verified By: ________________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Verification of Man Machine Interface Screens – MMI (PC Control)
Rationale – To verify that the screens displayed by the MMI according to the system requirements.

Test Required – None Required

Procedure – Access the MMI and verify that all of the functions on each of the screens listed below confirm to the Manual. Record the results for each verification on test data sheets.
Acceptance Criteria – The system shall operate as per design specification. Results: MMI screen verification

Simulate	Procedure	Excepted Result	Meets Test (Yes / No)	Initial / Date
Start Up Screen	This screen will displayed whenever the pc controls system starts	Operator station will Display the Start Up screen at the startup.
Menu Screen	Press any of the command buttons on the screen and check whether that particular screen opens.	Particular screen should open irrespective of the current security level in which user has logged.
Process Parameter Screen	Change the m/c. parameters like min/ max and set point values and accordingly check the result of the process functioning	The machine will operate according to the set values.
Alarm Screen	Click the alarm button from any screen	The alarm screen will activate.

Conclusions / Comments:
PASS FAIL
Verified By: ________________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Power & Communication Failure Recovery Verification
Rationale – To verify that in the event of a power loss or communications failure, the equipment /PLC will stop in safe condition and the operating parameter will not be lost or corrupted.

Test equipment – None Required.

Procedure for main power fail test –
- Operate the equipment in automatic mode or as directed in the User Manual.
- Record three of the configurable operating parameters in the main power fail test table of results (below).
- Record the displayed date and time in the main power fail test table of results (below).
- While the equipment/PLC is operating, shut down the power to the main control panel. Record if the equipment/PLC stops in a safe and secure condition.
- Wait for 3 minutes then restore power to the equipment/ PLC.
- Restart the equipment/ PLC. Record whether the equipment/PLC starts normally, and note any adverse condition.
- Verify that the parameters recorded in the step 2 are unchanged after the power failure.
- Record the displayed date and time after the power failure.

Acceptance criteria –
- At step 4, the equipment/PLC shall stop in safe and secure condition.
- At step 6, the equipment/PLC shall restart normally, with no problems or adverse conditions.
- After restart, the configurable parameters remain unchanged and the date and time are correct.
Main Power Failure Test Results

Main Power Fail Verification
Test	Results		Meets Test (Yes / No)	Initial / Date
Configurable Parameters before shut down.	Parameter 1: _______________ Parameter 2: _______________ Parameter 3: _______________
Main Power Shut Down	Equipment/PLC stops in a safe and secure condition.
Main Power Restored	Equipment/PLC can be restarted with NO problems or adverse conditions.
Configurable parameters after shut down.	Parameter 1: _______________ Parameter 2: _______________ Parameter 3: _______________
Date and time as displayed	Before shut down:	After shut down:

Conclusions / Comments:
PASS FAIL
Verified By: ________________________ Date: ______________
Reviewed By: ________________________ Date: ______________

Emergency Operation Verification
Purpose – To deactivate the equipment in the event of an emergency stop.

Test equipment – None Required.

Procedure –
- With the emergency stop pressed in, try to cause movement of an operating function.
- With the equipment in operation, activate (press in) the emergency stop.
Acceptance Criteria –
- The equipment will be inoperative.
- The operation will ramp to a complete stop in four seconds or less.
Failsafe Results –

Emergency Stop
Test	Acceptance Criteria	Meets Spec. (Yes / No)	Initial / Date
With the emergency stop pressed in, try to cause movement of an operating function.	The equipment will be inoperative.
With the equipment in operation, activate (press in) the emergency stop.	The operation will ramp to a complete stop in four seconds or less.

Conclusions / Comments:
PASS FAIL
Verified By: ________________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Verification of Alarms.

Rationale – To verify alarms function and respond according to the system design.

Test equipment – None Required.

Procedure –
- Place the equipment into normal operation mode.
- Trigger each alarm outline in the table below.
- Verify that the specified alarm response is obtained and the correct alarm is displayed on the MMI Screen.
- Once the alarm has been activated, resolve the problem and reset.
- Verify that the equipment returns to normal operation mode.
Acceptance criteria –
- The alarms function and respond according to the system design.

Results: Verification of Alarms

Alarm Verification
Simulation	Procedure	Excepted Result	Actual Result as Expected? (Yes / No)	Initial / Date mm/dd/yy
Air Pressure Minimum	Release air	Machine stops at Zero position
Front guard open	Open the guards	Machine stops at Zero position
Water supply off	Stop the water supply	Machine stops at Zero position
Low air supply	Reduce the air supply	Machine stops at Zero position
PVC foil end	Remove PVC foil	Machine stops at Zero position
Vacuum pump off	Stop the vacuum pump	Machine stops at Zero position
MCB trip	Put off MCB	Machine stops at Zero position
Sealing locks	Not operated	Machine stops at Zero position

Conclusions / Comments:
PASS FAIL
Verified By: ________________________ Date: ______________
Reviewed By: ________________________ Date: ______________

Operational Qualification Tests Status
The table below lists the tests performed and related results.

Test Number	Critical Feature	Pass / Fail		Deviation Found
Test Number	Critical Feature	Pass	Fail	Yes	No
	Testing of Programmable Logic Controller’s Processor
	Verification of Man Machine Interface Screens – MMI
	Power & Emergency Failure Recovery Verification
	Emergency Operation Verification
	Verification of Alarms

LIST OF STANDARD OPERATING PROCEDURES

S. No.	Description	SOP No	Verified By	Date
1	Operating Procedure of Blister Packing Machine (BQS)
2	Cleaning Procedure of Blister Packing Machine (BQS)
3	Preventive maintenance of Blister Packing Machine (BQS)

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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SOP for Operational qualification protocol of Blister Packing Machine (BQS)

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SOP for Operational qualification protocol of Blister Packing Machine (BQS)

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