BLISTER PACK MACHINE
REQUALIFICATION PROTOCOL CUM
REPORT
Equipment ID No.: PKG/ALU/001
Effective Date: __________________
Due Date: ___________________
INDEX
Sr. DESCRIPTION
Page No.
No.
1.0 PROTOCOL APPROVAL 3
2.0 OVERVIEW: 4-6
2.1 Objective 4
2.2 Purpose 4
2.3 Scope 4
2.4 Responsibility 4-5
2.5 Execution Team 6
3.0 ACCEPTANCE CRITERIA 7
4.0 REQUALIFICATION CRITERIA 7
5.0 INSTRUCTION FOR FILLING THE CHECKLIST 7
86.0 REQUALIFICATION PROCEDURE 8-9
6.1 EQUIPMENT DESCRIPTION 8
6.2 RISK ANALYSIS 9
7.0 VERIFICATION OF FUNCTIONAL CHECKS 9-11
8.0 VERIFICATION OF SAFETY FEATURES 11
9.0 VERIFICATION OF UTILITY 12
10.0 VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP) 12
11.0 VERIFICATION OF CALIBRATION OF THE MEASURING COMPONENTS 13
12.0 TEST INSTRUMENT DETAILS 13
13.0 PREVENTIVE MAINTENANCE AND BREAKDOWN 14
14.0 DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S) 15
15.0 LIST OF ANNEXURES 15
16.0 REQUALIFICATION FINAL REPORT 15
16.1 Summary 15
16.2 Conclusion 15
17.0 FINAL REPORT APPROVAL 16
PROTOCOL APPROVAL:
1.0
Signing of this approval page of Protocol indicates agreement with the requalification approach described in
this document. If modification to the requalification approach becomes necessary, an addendum shall be
prepared and approved.
The protocol cannot be used for execution unless approved by the following authorities.
This requalification protocol of Blister Pack Machine has been reviewed and approved by the following
persons:
This protocol is prepared by validation task force member
Department Quality Assurance
Signature
Name
Designation
Date
This protocol is reviewed by validation core committee
Department
Signature
Name
Designation
Date
This protocol is approved for implementation by Head Operation
Signature
Name
Designation
Date
2.0 OVERVIEW:
2.1 OBJECTIVE:
The objective of this protocol is to demonstrate and provide documented evidence that the
Blister Machine meets acceptance criteria when challenge the operational sequence.
2.2 PURPOSE:
The purpose of this protocol is to meet above objective.
2.3 SCOPE:
The Scope of this protocol is limited to the requalification of Blister Strip (Alu-Alu) Machine
in Anchor Pharma Pvt. Ltd, Ringanwada, Daman.
2.4 Responsibility:
2.4.1 Execution Team (Comprising members from Production, Engineering and Quality
Assurance)
Prepares the equipment requalification protocol.
Ensures that the protocol complies with current policies and procedures on equipment
requalification.
Distributes the finalized protocol for review and approval signatures.
Execution of this protocol.
Review of protocol, the completed qualification data package, and the final report.
Engineering personnel shall carry out the installation checks, operational checks,
calibration, SOP verification, features and utility verification.
The production operator/supervisor shall carry out the cleaning and operation of
machine and support for execution.
2.0 OVERVIEW: [Conti…..]
2.4 Responsibility: [Conti…]
2.4.2 Head – Production/ Engineering
Review and Approval of protocol, the completed requalification data package, and the
final report.
Assist in the resolution of validation deficiencies.
2.4.3 Head – Operation / Manager-Quality Assurance
Review and Approval of protocol, the completed qualification data package, and the
final report.
Assist the system user in the execution of the protocol.
Verification that the protocol test requirements are completed and properly
documented for approval.
Assist in the resolution of validation variances.
2.5 EXECUTION TEAM:
The satisfactory operation of the Blister Strip (Alu-Alu) Machine shall be verified by
executing the re-qualification studies described in this protocol. The successfully executed
protocol documents that the Blister Strip (Alu-Alu) Machine is operational and is satisfactorily
working.
Execution team is responsible for the execution of re-qualification of the Blister Machine (Alu-
Alu). Execution team comprises of:
NAME DESIGNATION DEPARTMENT SIGNATURE DATE
3.0 ACCEPTANCE CRITERIA:
3.1 All Standard Operating Procedure shall be verified.
3.2 All the measuring parameters shall be verified.
3.3 All the associated assemblies of the equipment shall be checked.
3.4 All the functional checks shall be carried out.
3.5 All the safety features shall be verified.
3.6 All the interlocks and alarms shall be verified for its proper functioning.
3.7 The availability of utilities for the equipment shall be verified.
3.8 All the measuring gauges and the test instruments shall be verified for its validity of calibration.
4.0 REQUALIFICATION CRITERIA:
The machine shall be re-qualified if:
There are any major changes, which affect the performance of the equipment.
After major breakdown, maintenance is carried out.
5.0 INSTRUCTIONS FOR FILLING THE CHECKLIST:
5.1 In case of the compliance of the test, write actual observation otherwise use ‘Does not comply’ to
indicate non-compliance.
5.2 If the result complies with the acceptance limit, use the word ‘Pass’ or in case of failure of the result
use the word ‘Fails’ to indicate the non-compliance.
5.3 Give the detailed information in the summary and conclusion part of the re-qualification protocol.
5.4 Whichever column is blank or not used ‘NA’ shall be used.
6.0 REQUALIFICATION PROCEDURE:
6.1 EQUIPMENT DESCRIPTION:
Check the following details on the machine and record in following table.
Equipment Name : STRIP MACHINE (ALU-ALU)
Manufacturer : MAK Engineers
Equipment Id. : PKG/ALU/001
Capacity : Single Track
Service it offers : For Packing of Tablets/Capsules
Location : Packaging area
Remarks: (If Any): _________________________________________________________________________
________________________________________________________________________________________
Checked By & Date:
Verified By & Date:
RISK ANALYSIS:
The Blister Machine (Alu-Alu) already installed in general packing area, material of
construction and several other features of equipment has already verified during initial
6.2 qualification, and as such machine has been used since long period and the risk is minimum to
the machine since most of the parameters have already been verified.
Requalification of equipment shall be performed and risk associated with the equipment shall
be identified.
Risk Identified Control Measures
Guard interlocks have been provided, once guard opens machine
The moving part of equipment may stops. Guard interlocks shall be challenged during the performance of
injure the operator. operational qualification. All the moving parts have been covered for
operator safety.
Vibration of turret will lead to Vibration shall be verified to demonstrate that there are no
various discrepancies related to discrepancies in Vibration observed which shall be verified during
tablet. execution of qualification activity.
7.0 VERIFICATION OF FUCTIONAL CHECKS:
CHECKED
Sr. NAME OF SYSTEM
SPECIFIED FUNCTION OBSERVATIONS BY
No. COMPONENT
SIGN/ DATE
Control Panel of Machine should
1. Main switch on/off
Start/Stop
Press the Black push
2. button on the Machine The Machine should stop.
Controls screen
Press the Blue button on
3. the Machine Controls Alarm shall be reset.
screen
Alarm system in any Shall be available and alarm
4.
troubleshooting should be made.
The charging port is provided for
Charging and discharge loading of tablets/capsules.
5.
port
Another port should be provided.
Water pump shall be available in
6. Water pump
working condition.
Machine should trip immediately
7. Emergency stop
after pressing the button
Heater shall be available in
8. Forming heater
working condition
Cooler shall be available in
10. Water Cooler
working condition
Heater shall be available in
11. Sealing heater
working condition
CHECKED
Sr. NAME OF SYSTEM
SPECIFIED FUNCTION OBSERVATIONS BY
No. COMPONENT
SIGN/ DATE
Sealing temperature Temperature indicator shall be
12.
indicator available in working condition
Forming Temperature indicator
Forming Temperature
13. shall be available in working
Indicator
condition
Motor details
Non Flame proof, 3 phase
Type
induction motor
14.
HP 5
Voltage 415 V
Frequency 50 ± 5% Hz
Make: Premium
16. Gear box details Size: U-400
Type: STU
Remarks: (If any)
_________________________________________________________________________________________
_________________________________________________________________________________________
Checked By & Date:
Verified By & Date:
8.0 VERIFICATION OF SAFETY FEATURES:
SAFETY
FEATURES FUNCTION OBSERVATION
DESCRIPTION
Earthing To avoid the shock due to power leakage.
To stop the machine if problem appears in
Emergency stop button
running condition.
SAFETY
FEATURES FUNCTION OBSERVATION
DESCRIPTION
Railing should be provided all around the
frame.
Safety features Limit switches should be provided on railing
and end panel.
Motor, Gear box, chain etc., should be
enclosed in SS cover.
Remarks: (If Any): ________________________________________________________________________
_________________________________________________________________________________________
Checked By & Date:
Verified By & Date:
9.0 VERIFICATION OF UTILITY:
UTILITY REQUIRED SPECIFICATION OBSERVATION
Voltage 415 ± 10% V
Phase Three phase
Frequency 50 ± 5% HZ
Remarks: (If any): _________________________________________________________________________
_______________________________________________________________________________________
Checked By & Date:
Verified By & Date:
10.0 VERIFICATION OF STANDARD OPERATING PROCEDURE (SOP)
The following Standard Operating Procedures were verified as important for effective performance of Blister
Machine.
SOP CHECKED
SOP TITLE DATE
NUMBER BY
1. Operation of Blister Machine
2. Cleaning of Blister Machine
3. Preventive Maintenance Blister Machine
Remarks: (If any):_________________________________________________________________________
_________________________________________________________________________________
Checked By & Date:
Verified By & Date:
11.0 VERIFICATION OF CALIBRATION OF THE MEASURING COMPONENTS:
Name of Identification Calibration Calibration Certificate Checked by sign
components number done on due on number / date
Remarks: (If any):_______________________________________________________________________
____________________________________________________________________________________
Checked By & Date:
Verified By & Date:
12.0 TEST INSTRUMENT DETAILS:
Objective: This test is intended to describe the test instruments used for the verification of the
Calibration of measuring components of Blister Machine (Alu-Alu).
Calibration
Instrument Instrument Calibration Calibration Checked
Sr. No. certificate
Name ID. No. done on due on by/Date
number
Remarks: (If any): _______________________________________________________________________
__________________________________________________________________________________
Checked By & Date:
Verified By & Date:
13.0 PREVENTIVE MAINTENANCE AND BREAKDOWN:
Breakdown maintenance
Sr. No. Checkpoints Observation Signature Remark
1. Number of times
Whether any part replaced. If
2.
yes, then write the details.
Whether validation was
3. required. If yes, status of
validation
Any change in SOP with the
4. above breakdown. If yes,
specify the status of the change
5. Any other changes (if any)
Preventive maintenance
Sr. No. Checkpoints Observation Signature Remark
Any abnormal observations
1. made during the preventive
maintenance
If observations made, specify
2.
the details
3. Any other changes (if any)
Remarks: (If any): ________________________________________________________________________
_______________________________________________________________________________________
Checked By & Date:
Verified By & Date:
14.0 DEFICIENCY AND CORRECTIVE ACTION (S) REPORT (S):
Following deficiency was verified and corrective actions taken.
Description of Deficiency:
Corrective action(s) taken:
Deviation Accepted by: Deviation Approved by:
(Sign/Date) (Sign/Date)
15.0 LIST OF ANNEXURES:
Annexure No. Document Title
Remarks (if any): ________________________________________________________________________
______________________________________________________________________________________
Done By & Date: Verified By & Date:
16.0 REQUALIFICATION FINAL REPORT:
16.1 SUMMARY:
16.2 CONCLUSION:
Prepared By & Date: Verified By & Date:
17.0 FINAL REPORT APPROVAL:
It has been verified that all tests required by this protocol are completed, reconciled and attached to this protocol
or included in the requalification summary report. Verified that all amendments and discrepancies are
documented, approved and attached to this protocol.
Signature in the block below indicate that all items in the requalification report have been reviewed and found
to be acceptable and that all variations or discrepancies have been satisfactorily resolved.
FUNCTION NAME DESIGNATION DEPARTMENT SIGN/DATE
QUALITY
SHUBHAM PATEL OFFICER
ASSURANCE
SHAILESH HEAD
REVIEWED ENGINEERING
VISHWAKARMA ENGINEERING
BY
HEAD
VISHESH BARIA PRODUCTION
PRODUCTION
QUALITY
HIREN SOLANKI EXECUTIVE
ASSURANCE
QUALITY
DIKSHITA PATEL HEAD QA
ASSURANCE
APPROVED
BY
GENERAL HEAD
PARTH PATEL
MANAGER OPERATION