Performance Qualification

Protocol for
Compression Machine
No:CPMA0001

Aurobindo Pharma ltd.,

Unit VII, Jadcherla,
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

TABLE OF CONTENTS

1.0 PROTOCOL APPROVAL_____________________________________________________2

2.0 OBJECTIVE________________________________________________________________3
3.0 SCOPE____________________________________________________________________3
4.0 EXECUTION TEAM_________________________________________________________4
5.0 SYSTEM QUALIFICATION__________________________________________________5
5.1 TEST DATA_____________________________________________________________5
5.1.1 Test run with placebo blend/product___________________________________________6
6.0 DISCREPANCY AND CORRECTIVE ACTION REPORT__________________________9
7.0 FINAL REPORT___________________________________________________________10
7.1 Summary_______________________________________________________________10
7.2 Conclusion______________________________________________________________10
8.0 REPORT APPROVAL______________________________________________________11
9.0 APPENDIX________________________________________________________________12
9.1 Abbreviations____________________________________________________________12
9.2 Reference Documents_____________________________________________________12

Page 1 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

1.0 PROTOCOL APPROVAL

Signing of this approval page of protocol indicates agreement with the qualification approach
described in this document. If any modifications in the system qualification approach become
necessary, an addendum shall be prepared, checked and approved. This protocol cannot be
executed until approved by following personnel.

Department Name Signature /Date

Prepared by:
Preparation of this qualification protocol is the responsibility of Validation Coordinator.

Quality Assurance

Checked by:
Checking of this qualification protocol is the responsibility of Validation Task force leader

Quality Assurance

Approved by:
Approval of this qualification protocol is the responsibility of the Validation Core Committee.

Production

Engineering

Quality Assurance

Page 2 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

2.0 OBJECTIVE
The objective of this Performance Qualification Protocol is to provide guideline for verification of
dynamic attributes of Compression Machine, (Eqpt No: CPMA0001) catering environmental
conditions to at Aurobindo Pharma Unit VII, Jadcherla with reference to batch No VLSA09001

- To verify the performance of the Compression machine (63 stn) at different

compression speeds and air pressures.
- To evaluate the performance of the equipment / system under various operational
conditions.
- Assures that the equipment / system performance is adequate to support the
process, for which it is intended for.

Note: Machine’s performance was evaluated for production of conventional

tablets (Tooling-B type, 10.0 mm X 5.0 mm Ovaloid, concave, beveled edge).
Embossing: Upper Punch_______
Lower Punch_______

3.0 SCOPE

The scope of this protocol applies for Performance Qualification of the subjected Compression
Machine within the following boundaries
.
 Test run with Valsartan common blend

Page 3 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

4.0 EXECUTION TEAM

Department Responsibility
Execute the validation activity and provide necessary support for the proper
Engineering
operation of the system
Execute the validation activity and provide the necessary support the proper
User
operation of the system
Quality
Monitoring and reviewing the validation activities
Assurance

SIGNATURE LOG

Personnel signing in below table indicate that they were trained in qualification approaches
mentioned in this validation document

Name Department Signature/date

Page 4 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

5.0 SYSTEM QUALIFICATION

The following qualification activities for the PQ are listed. Successful execution of the
activities listed shall complete the Performance qualification of Compression Machine-63
Station; CPMA0001

1. Test run with Valsartan common blend/product

The qualification activities listed above provide a documented verification of the Performance
of the system as per the specifications / requirements.
The purpose of performing the tests, methodology of performing / executing the same and
provision for recording the results is outlined in step 5.1 of this protocol.

5.1 TEST DATA

The detailed procedure for execution of each test described above along with the
provision for recording the observations is given in the following pages.

Page 5 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

5.1.1 Test run with Valsartan common blend/product

Objective:

 Objective of this test is to evaluate the performance of equipment at various speeds

using Valsartan common blend.
 Raw material requirement data and compressed tablet Physical parameters shall
meet the acceptance criteria.

References and Tools Required:

S. Description Equipment Calibrated Calibration

No. No. on due
1. Electronic Balance BALA0003,
BALA0037
2. Friability Test Apparatus FRBA00001
3. DT Apparatus DTAA0001
4. Hardness Tester HTDA0001

Raw material requirement:

S. No. Description Quantity Checked

By
1 Valsartan Tablets 40/80160/320 mg common 24.050 kg
blend

Note:
Observed bulk density of the dummy Granules: ______

Page 6 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Procedure:

 Manually load the material in to the hopper of the compression machine.

 Operate the compression machine at low speed (__________tablets/hr) as per Operating

Instructions.

 Run the machine for 30 minutes continuously after adjusting the following
parameters.
1. Theoretical weight
2. Weight of 20 tablets
3. Hardness
4. Thickness
5. Disintegration time
6. Friability

 Repeat the experiment for the both medium (______ _____tablets/hr) and high
speed (______ _______tablets/hr) with same set of parameters and attach the
results.

Sampling Plan:

Collect 75 tablets for every 10 minutes.

Page 7 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression machine System No.: CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Acceptance Criteria:

Compressed tablet shall meet the following parameters:

S. No Parameter Acceptance Criteria

White to off white, ovalid, beveled edge,

biconvex tablets debossed with ‘I’ on one side
1 Appearance
and ‘73’ on other side with score line
separating 7&3.
2 Weight of 10 Tablets 1.203 g± 3%(1.167-1.239)
3 Hardness 3.0 to 11.0 kp
4 Thickness 3.40 ± 0.3 mm
5 DT time NMT 15 Min
6 Friability NMT 1 %
120.25 mg ± 7.5 %
7 Uniformity of weight.
(111.23 – 129.27 mg)

Page 8 of 12
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Annexure-1
Test Run with Load
Product Name: Batch No.:

Sl.No. Parameters Acceptance Criteria 10 min 20 min 30 min Checked

LHS RHS LHS RHS LHS RHS By/ date
Speed : Slow (_________tab/hr) Feeder RPM: Compaction Force :
1. Weight of 20 tablets
2. DT time
3. Friability
Speed : Medium(_________tab/hr) Feeder RPM: Compaction Force :
1. Weight of 20 tablets
2. DT time
3. Friability
Speed : Fast (_________tab/hr) Feeder RPM: Compaction Force :
1. Weight of 20 tablets
2. DT time
3. Friability
Comments:
Reviewed by Sign: ____________________ Date: ______________________

Page No.: 1 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Slow

Batch No.: Feeder rpm:
Compaction Force:
Time Individual Weight Variation of the tablet (in mg)__________ ± 7.5 %
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 2 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Slow

Batch No.: Feeder rpm:
Compaction Force:
Time Hardness (in Kp)
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 3 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Medium

Batch No.: Feeder rpm:
Compaction Force:
Time Individual Weight Variation of the tablet (in mg) __________ ± 5 %
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 4 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Medium

Batch No.: Feeder rpm:
Compaction Force:
Time Hardness (in Kp)
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 5 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : High

Batch No.: Feeder rpm:
Compaction Force:
Time Individual Weight Variation of the tablet (in mg) _________ ± 5 %
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 6 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : High

Batch No.: Feeder rpm:
Compaction Force:
Time Hardness (in Kp)
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:

Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 7 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Low

Batch No.: Feeder rpm:
Compaction Force:
Time Thickness (in mm )
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:
Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 8 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed : Medium

Batch No.: Feeder rpm:
Compaction Force:
Time Thickness (in mm)
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

LHS
30 min
RHS

Comments:
Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 9 of 10
 PERFORMANCE QUALIFICATION
System Name: Compression machine – 63 Station System No. : CPMA0001
Protocol No : PQ/CPMA0001/A1-00 Effective Date :

Product Name: Speed: High

Batch No.: Feeder rpm:
Compaction Force:
Time Thickness (in mm)
1 2 3 4 5 6 7 8 9 10

LHS
10 min
RHS

LHS
20 min
RHS

30 min LHS

RHS

Comments:
Checked by Sign/Date: ____________________ Reviewed by Sign/Date: ______________________

Page No.: 10 of 10
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression Machine System No. : CPMA0001
Protocol Number: PQ/CPMA0001/A1-00 Effective Date:

6.0 DISCREPANCY AND CORRECTIVE ACTION REPORT

Document any discrepancies observed during the Performance Qualification of the equipment.
Include the corrective actions of the same. When all the discrepancies are satisfactorily resolved or
an approved action plan is developed which ensures that the discrepancy will be resolved,
document that the system is ready for operational qualification.

Test Critical feature Discrepancy Corrective Checked by/

YES/NO Action date

Remarks:

Reviewed by: ____________________ Date: ______________________

Page 9 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression Machine System No. : CPMA0001
Protocol Number: PQ/CPMA0001/A1-00 Effective Date:

7.0 FINAL REPORT

7.1 Summary
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7.2 Conclusion

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Page 10 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression Machine System No. : CPMA0001
Protocol Number: PQ/CPMA0001/A1-00 Effective Date:

8.0 REPORT APPROVAL

Verified that all test cases required by this protocol are completed, reconciled and attached to this
protocol or included in the qualification summary report.

Signatures in the block below indicate that all items in this Qualification Protocol
have been reviewed and found to be acceptable.

Department Name Signature /Date

Checked By

Quality Assurance

Approved by

Production

Engineering

Quality assurance

The system is READY FOR OPERATIONAL USE

Page 11 of 12
 QUALIFICATION PROTOCOL ADDENDUM
System Name: Compression Machine System No. : CPMA0001
Protocol Number: PQ/CPMA0001/A1-00 Effective Date:

9.0 APPENDIX

9.1 Abbreviations
RPM Rotations per minute

PQ Performance qualifications

KP Kilo Pascal’s

NMT Not more than

DT Disintegration time

Mm millimeters

9.2 Reference Documents

_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
___________________________________________________________________

Page 12 of 12
 Page for Pasting of Weights Print
System No: Protocol Number: PQ/CPMA0001-00

Speed:__________tab/hr feeder RPM:_________ Compaction force:_____

10 MIN
LHS RHS

20 MIN
LHS RHS

30 MIN
LHS RHS

Checked by:___________ Reviewed by:__________

 Page for Pasting of Weights Print
System No: Protocol Number: PQ/CPMA0001-00