Performance Qualification Protocol for Blister Machine is designed to provide documented evidence that the functions of the equipment, which affect the product quality, equipment integrity, and safety of operating and maintenance personnel are considered.
SERIAL NO.
ITEM DESCRIPTION
1.0
PROTOCOL APPROVAL
2.0
OVERVIEW:
2.1
Objective
2.2
Purpose
2.3
Scope
2.4
Responsibility
2.5
Execution Team
3.0
GENERAL CONSIDERATION/PREREQUISITE
4.0
REVALIDATION CRITERIA
5.0
PERFORMANCE QUALIFICATION PROCEDURE
5.1
Methodology
6.0
ACCEPTANCE Criteria
7.0
Challenge test Sheet
8.0
DEFICIENCY AND CORRECTIVE ACTIONS
9.0
Annexure(s)
10.0
Performance qualification final report
10.1
Summary
10.2
Conclusion
10.3
Final Report Approval
1.0
PROTOCOL APPROVAL:
This Performance Qualification Report of the Blister packing machine has been reviewed and approved by the following signatories:
The objective of developing and executing this protocol is to check and document the performance of equipment in the established/ predetermined operating ranges.
2.2
PURPOSE:
The purpose of this protocol is to provide documented evidence that the functions of the equipment, which affect the product quality, equipment integrity, and safety of operating and maintenance personnel are taken into consideration.
2.3
SCOPE:
The scope protocol shall define the test procedures, documentation, and acceptance criteria to establish that the operational parameters of the Blister packing machine are as per the requirement.
2.4
RESPONSIBILITY:
The following persons shall be responsible;
Quality assurance officer/ Executive – For Preparation of Protocol /Execution Projects. Engineering Head – For the execution. Production Head – For execution. support Quality Assurance Head – For verification of adequacy and final approval
2.5
EXECUTION TEAM:
The satisfactory operation of the Blister packing machine shall be verified by executing the performance qualification studies described in this protocol. The successfully executed protocol documents that the Blister packing machine is operational and is satisfactorily working. The execution team is responsible for the execution of performance qualification of the Blister packing machine. The execution team comprises of:
DEPARTMENT
DESIGNATION
NAME
SIGNATURE
DATE
PROJECTS/ENGG.
PRODUCTION
QUALITY ASSURANCE
3.0
GENERAL CONSIDERATION/ PREREQUISITE:
3.1
Approved Standard operating procedure of the Blister packing M/C shall be available.
3.2
The impact analysis of the equipment shall be recorded in the summary sheet.
All the deficiencies and discrepancies related to the equipment that affect the product quality and corrective action taken shall be recorded in the appropriate section of the protocol.
3.5
After completion of PQ activities, equipment shall be cleaned as per respective cleaning SOPs and released for manufacturing.
3.6
All the measuring parameters shall be verified.
3.7
All the safety features shall be verified.
3.8
The availability of utilities for the equipment shall be verified.
4.0
REVALIDATION CRITERIA:
The machine shall be requalified if:
Any major changes affect the performance of the equipment. After major breakdown maintenance is carried out. As per the revalidation date and schedule
5.0
Performance qualification procedure:
5.1
Methodology:
Read all notes for each step before beginning the test steps. Verify and record verification of all critical operational functions. Challenge each of the control systems and each sub-system. Identify and correct any function, system, or subsystem that fails a specific challenge before proceeding to the next section of the testing criteria. Document and obtain approval for any modification to the equipment aimed at ensuring compliance with the operation, process, or Qualification Protocol before completing the challenged section. Challenge any modification that affects the operation of the equipment. Each challenge will be generated and approved by each department. If any additional raw data is generated during the implementation of this Protocol, all raw data must be identified and included/referenced in the “Annexure(s) “section of this Protocol.
5.1.1
Pass PVC through the Pressure heating roller (PHR) and then the Blister forming roller (BFR) and ensure the formation of the blister.
5.1.2
Tablets are placed in a hopper and ensure that tablets are feeded in blisters through a brush feeder.
5.1.3
Ensure that waves are sealed in a counter sealing roller (CSR) with the help of a pressure sealing roller.
5.1.4
Ensure that aluminium foil is overprinted in the Batch Code Printer (BCP) clearly.
5.1.5
Ensure that waves pass through the indexing guide into the punching tool for proper blister cutting.
5.1.6
Repeat points 5.1.1, 5.1.2, 5.1.3 & 5.1.4 for at least 10 times until repeatability is confirmed.
6.0
ACCEPTANCE CRITERIA
The test will be considered failed if the actual test results do not correspond to the expected results as detailed at each test step. Each test step must be completed prior to proceeding to the following step.
NAME OF TEST
SPECIFIED FUNCTION
OBSERVATIONS
VERIFIED BY(SIGN)
DATE
Physical Checks
Proper size of the blister. Proper formation of blisters. Proper formation of knurling. Proper over-printing Absence of torn pocket, press pocket, and pinhole. Broken tablets.
Leak Test
A leak test was performed at 381 mm of Hg negative pressure for 1 minute to check proper sealing.
7.0
Challenge test sheet
Step
Challenged
OBSERVATIONS
VerifiedBY(SIGN)
Date
1.
PHR temperature crosses the specified limit.
2.
PSR temperature is lower than the specified limit.
3.
PSR temperature higher side than the specified limit.
4.
Blister packs are subjected to leak test, each parameter within specification.
5.
After maintaining all parameters within specification physical appearance of the finished pack was found satisfactory.
The following deficiency was verified and corrective actions were taken.
Description of deficiency :
Corrective action(s) taken :
Reviewed By:
Date:
9.0 Annexure (s):
Sr.No.
Annexure No.
Title of Annexure
10.0
PERFORMATION QUALIFICATION FINAL REPORT:
10.1
SUMMARY :
10.2
CONCLUSION :
10.3 FINAL REPORT APPROVAL
It has been verified that all tests required by this Performance Qualification Protocol are completed, reconciled, and attached to this protocol or included in the qualification summary report. Verified that all amendments and discrepancies are documented, approved, and attached to this protocol.
The signature in the block below indicates 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.
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