NAAFCO Pharma Ltd. Bhaluka, Mymensingh Title: Performance Qualification Report For Hoonga-Blister Machine
NAAFCO Pharma Ltd. Bhaluka, Mymensingh Title: Performance Qualification Report For Hoonga-Blister Machine
NAAFCO Pharma Ltd. Bhaluka, Mymensingh Title: Performance Qualification Report For Hoonga-Blister Machine
Bhaluka, Mymensingh
APPROVALS
NPL Approvals Name Designatio Signature Date
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Prepared By:
Checked By:
Reviewed By:
Approve by:
CONTENTS
1.0 INTRODUCTION:
Qualification is the planning carrying out and recording of test on equipment of tests on
equipment and systems which will form a part of the validated process to demonstrate that
it will perform as intended.
Qualification of instrument /equipment is not a single, continuous process but instead
results from many discrete activities .Qualification requirements of established
equipment /instruments are decided on the basis of performance data of that equipment.
2.0 OBJECTIVE
To determine that the blistering Machine PBM (HMV3) installed at packaging Section at
square pharmaceuticals Ltd. Perform as intended by repeatedly running the system on its
intended schedules and recording all relevant information and data.
Results must demonstrate that performance consistently meets predetermined
specifications under normal conditions and where appropriate for worse case situations.
3.0 SCOPE
This study is applicable to the performance qualification test of Blistering machine PBM
(HM V3) Weather the equipment can perform effectively and reproducibly based on
approved specification.
4.0 RESPONSIBILITY
4.1 Quality Assurance department
Prepare the protocol
Conduct the validation trials
Develop the sampling Plan (I.e Sampling location ,sample size sampling time and
procedure for collecting sample)
Collect samples and arrange analysis for testing
Accumulate complile and summarize all test results.
Generate Validation report and circulate for approval .
Comments Satisfactory
Result: Pass/Fail Pass
20mins
Batch No.
1st 20 Well Well Well Well Well Well
mins
Middle Well Well Well Well Well Well
20 mins
Last Well Well Well Well Well Well
20mins
Batch No.
1st 20 Well Well Well Well Well Well
mins
Middle Well Well Well Well Well Well
20 mins
Last Well Well Well Well Well Well
20mins
Comments Satisfactory
Result:Pass/Fail Pass
7.0 DEVIATION
Deviation:
There was no deviation in the blistering process or physical and testing parameters
of final products.
Justification for acceptance
No other abnormality was observed.
Impact on operation :
The physical appearance of the product was satisfactory.
three products. Products packed with primary packaging material found exit smoothly
through the delivery channel and machine was satisfactory.
The aforementioned findings concluded that the performance of blister packaging
Machine (PBM11) is qualified for packaging with consistent of GMP.
9.0 CONCLUSION
Review of the data generated by this study shows that the automatic blister packaging
machine(PBM11) installed in the online section of solid dosage form at square
pharmaceuticals Ltd. Meets all of the acceptance criteria for the performance qualification.
All items in the test sections of this protocol have been satisfactory completed. The Unit is
therefore considered ready for use for normal production operations.
10.0 APPROVAL
Based on the result reported & summary in the Validation reports, Validation study is
Approved
Not Approved