NAAFCO Pharma Ltd.

Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
RR
00 Next Review due date: Page No. 1 of 17

PERFORMANCE QUILIFICATION REPORT

OF
HOONGA BLISTER MACHINE

Manufacturer : Hoong-A, Korea

Model: HM V3
Serial No: M5M000440
Equipment ID No: NPL-PRO-BPM-01
Location :

APPROVALS
NPL Approvals Name Designatio Signature Date
n
Prepared By:
Checked By:
Reviewed By:

Approve by:

CONTENTS

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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00 Next Review due date: Page No. 2 of 17

SL.No.. Title PAGE

NUMBER
1. INTRODUCTION 3
2. OBJECTIVE 3
3. SCOPE 3
5. RESPONSIBILITY 3
6. DOCUMENT VERIFICATION 4
7. PERFORMANCE TEST USING DIFFERENT PRODUCTS 5-15
8 DEVIATION 16
9. FINAL SUMMARY REPORTING 16
10. CONCLUSION 16
11. APPROVAL 17

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

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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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 .

4.2 Production Department

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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Arrange accessories as started in the protocol.

In conjunction with the development identity critical process parameters.
Schedule time availability to validation execution.

4.3 Engineering Department

Help Validation team in setting machine parameters as per protocol.
Ensure the calibration of instruments .
Participate as a team member of qualification.

5.0 DOCUMENTS VERIFICATION

5.1.1 Installation Qualification Document (IQ).

Installation qualification documents are verified and showed that the equipment has been
properly installed and qualified in accordance with standard. The document was approved
for the next step of operation.The document no.is ………….

5.1.2 Operational Qualification Document (OQ)

The Operation qualification documents observed that the test is performed in compliance
with the specifications.All tests were confirmed by the assigned responsible concerns
persons. The document no. is………………
5.1.3 Machine Calibration Status and SOP. No

Machine Name Machine Code Calibration Status

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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Hoonga Automatic Calibrated

Blister packing
machine

Standard Operating Procedure(SOP) No.

1.Setup And Operating Procedure SOP No:PR-SOP-025

2. Cleaning Procedure SOP No:PR-SOP-026

6.0 PERFORMANCE TEST USING DIFFERENT PRODUCTS

Product Name Batch No. & Manufacturing Date

6.1 PRODUCT NAME:

Performance is to be carried out with this batch and observations of the critical
parameters are to be recorded in given below table:
Batch No.

6.1.1 Machine Setting parameters

Product: Results: Pass/Fail
Test Parameters Accessories Criteria B/N: B/N: B/N:

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA

Title: Performance Qualification Report For Hoonga- Blister
Document No. Revision No.
RR
00
Preliminary
Preparation:
1 Using the operation
manual setup the
equipment as appropriate
.
Blister Forming
,Sealing Embossing
Cutting & Leak testing
challenge :
2 Challenge the ability of
the equipment to
consistently forming
perfect cavities ,product
feeding in the cavities
,sealing ,embossing
,perforation ,cutting and
finally leak test.
Enable the equipment
,satisfy all inputs for
normal operation and
then supply sufficient
blister to the equipment
and then operate the
Name
Prepared By Khandaker Tanvir Ahmed
Checked By Md. Awlad Hossain
Approved By Md. Nazrul Islam Khan
NAAFCO Pharma Ltd.
Bhaluka, Mymensingh
Machine
Date of Issued: Effective Date:
Next Review due date: Page No. 6 of 17
The equipment should
Pass Pass
run effectively according
to the set value.
All samples satisfy the Pass Pass
(Table:6.1.2) (Table:6.1.2 (Table:6.1.2)
criteria detailed below:
)
Blister forming
,Sealing ,Embossing,
Cutting &Leak test.
 Visual check accurate
forming cavities .
 Visual check accurate
feeding the cavities
 Visual check accurate
sealing .
 Visual check accurate
Embossing .
 Visual check accurate
perforation
 Visual check accurate
cutting .
 Visual check accurate
ejection.
Designation Signature Date
Production Officer
Production Manager
Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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machine.  Visual check accurate

Sampling : Take leak test.

10blisters of each  No Damaged Strips are

found
product form the drum
cutting for operation
challenge verification.

3 Faculty Management:  All unqualified products

Challenge the ability of should be rejected by

the equipment to the the system and

controlled onto the
consistently respond
collecting container.
upon faulty events.
Enable the equipment
 No Extra damages
,satisfy all inputs for Pass Pass
caused to faulty blister
normal operation
during rejection.
,randomly introduce the
following events:
 Remove faulty products.
 Missing Products
 Inspect the rejection tray

Comments Satisfactory
Result: Pass/Fail Pass

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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6.1.2 Performance Test Results:

Name of Product
Checking Parameter
Proper Proper Proper Proper Proper Proper
Forming Feeding Sealing Embossing Perforation Cuttin
g
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
Name Designation Signature Date
Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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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

6.2 Product Name:

Performance is to be carried out with this batch and observations of the critical
parameters are to be recorded in given below table:
Batch No.
6.2.1 Machine Setting Parameters

Product: Results: Pass/Fail

Test Parameters Accessories Criteria B/N: B/N: B/N:

Preliminary Preparation: The equipment should

Pass Pass
Using the operation run effectively according

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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1 manual setup the to the set value.

equipment as appropriate
Blister Forming ,Sealing All samples satisfy the Pass Pass
(Table:6.2.2) (Table:6.2.2 (Table:6.2.2)
Embossing Cutting & criteria detailed below:
)
Leak testing challenge : Blister forming
Challenge the ability of the ,Sealing ,Embossing,
2 equipment to consistently Cutting &Leak test.
forming perfect cavities  Visual check accurate
,product feeding in the forming cavities .

cavities ,sealing, emboss-  Visual check accurate

ing ,perforation ,cutting
and finally leak test.
Enable the equipment
,satisfy all inputs for
normal operation and then
supply sufficient blister to
the equipment and then
operate the machine.
Sampling : Take 10blisters
feeding the cavities
 Visual check accurate
sealing .
 Visual check accurate
Embossing .
 Visual check accurate
perforation
 Visual check accurate
cutting .
 Visual check accurate

of each product form the ejection.

drum cutting for operation
challenge verification.
3 Faculty Management:
 Visual check accurate
leak test.
 No Damaged Strips are
found
 All unqualified products

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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Challenge the ability of the should be rejected by

equipment to the the system and
consistently respond upon controlled onto the
faulty events.
collecting container.
Enable the equipment
,satisfy all inputs for
normal operation  No Extra damages
Pass Pass
,randomly introduce the caused to faulty blister
following events: during rejection.
 Remove faulty products.
 Missing Products
 Inspect the rejection tray
Comments Satisfactory
Result: Pass/Fail Pass

6.2.2. Performance Test Results:

Name of Product
Checking Parameter
Proper Proper Proper Proper Proper Proper
Forming Feeding Sealing Embossing Perforation Cuttin
g
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
Name Designation Signature Date
Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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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

6.3. Product Name:

Performance is to be carried out with this batch and observations of the critical parameters
are to be recorded in given below table:
Batch No.
6.3.1 Machine Setting Parameters
Product: Results: Pass/Fail
Test Parameters Accessories Criteria B/N: B/N: B/N:

Preliminary Preparation: The equipment should

Pass Pass
Using the operation run effectively according
1 manual setup the to the set value.
equipment as appropriate
Blister Forming ,Sealing All samples satisfy the Pass Pass
(Table:6.3.2) (Table:6.3.2 (Table:6.3.2)
Embossing Cutting & criteria detailed below:
)
Name Designation Signature Date
Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA

Title: Performance Qualification Report For Hoonga- Blister
Document No. Revision No.
RR
00
Leak testing challenge :
Challenge the ability of the
2 equipment to consistently
forming perfect cavities
,product feeding in the
cavities ,sealing, emboss-
ing ,perforation ,cutting
and finally leak test.
Enable the equipment
,satisfy all inputs for
normal operation and then
supply sufficient blister to
the equipment and then
operate the machine.
Sampling : Take 10blisters
of each product form the
drum cutting for operation
challenge verification.
3 Faculty Management:
Challenge the ability of the
equipment to the
consistently respond upon
faulty events.
Enable the equipment
Name
Prepared By Khandaker Tanvir Ahmed
Checked By Md. Awlad Hossain
Approved By Md. Nazrul Islam Khan
NAAFCO Pharma Ltd.
Bhaluka, Mymensingh
Machine
Date of Issued: Effective Date:
Next Review due date: Page No. 13 of 17
Blister forming
,Sealing ,Embossing,
Cutting &Leak test.
 Visual check accurate
forming cavities .
 Visual check accurate
feeding the cavities
 Visual check accurate
sealing .
 Visual check accurate
Embossing .
 Visual check accurate
perforation
 Visual check accurate
cutting .
 Visual check accurate
ejection.
 Visual check accurate
leak test.
 No Damaged Strips are
found
 All unqualified products
should be rejected by
the system and
controlled onto the
collecting container.
Designation Signature Date
Production Officer
Production Manager
Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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,satisfy all inputs for

normal operation  No Extra damages Pass Pass
,randomly introduce the
caused to faulty blister
following events:
 Remove faulty products. during rejection.
 Missing Products
 Inspect the rejection tray
Comments Satisfactory
Result: Pass/Fail Pass

6.3.2 Performance parameters

Name of Product
Checking Parameter
Proper Proper Proper Proper Proper Proper
Forming Feeding Sealing Embossing Perforation Cuttin
g
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

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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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.

8.0 FINAL SUMMARY REPORTING

Qualification is an essential part of a pharmaceutical manufacturer’s quality assurance
system. The Performance qualification of automatic blister packaging machine was done
using three commercial products.
Forming of blister feeding sealing perforation cutting found ok in each batch of selected
Name Designation Signature Date
Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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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

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA
 NAAFCO Pharma Ltd.
Bhaluka, Mymensingh

Title: Performance Qualification Report For Hoonga- Blister

Machine
Document No. Revision No. Date of Issued: Effective Date:
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00 Next Review due date: Page No. 17 of 17

Name Designation Signature Date

Prepared By Khandaker Tanvir Ahmed Production Officer
Checked By Md. Awlad Hossain Production Manager
Approved By Md. Nazrul Islam Khan Manager- QA