CARAWAY PHARMACEUTICALS

Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

Installation Qualification Protocol

Equipment Name: Tablet Compression Machine (ZP-31)

Equipment ID: CP/PRD/112

Protocol Number: IQ-001/09-2023

Department / Section: Tablet Section / Compression Room

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

CONTENTS

S. No. Description Page No.

1. Pre-Approval 3

2. Purpose/Objective 4

3. Scope 4

4. Responsibility 4

5. Qualification Study 4

6. Documentation 4

7. Machine Description 5

8. Acceptance Criteria 6

9. Installation Qualification Report 6

10. Checklist 6

11. Facilities 7

12. Tool kit supplied with Tablet Compression Machine (ZP-31) 7

13. Drawings/Reference Documents 7

14. Identification of Documentation 8

15. Observed Deviation 8

16. Recommendation 8

17. Change Control 8

18. Conclusion 8

19. Post Approval 9

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

1. Pre-Approval

Prepared By:

Validation Officer Signature Date

Reviewed By:

Production Manager Signature Date

Verified By:

Manager Quality Assurance Signature Date

Approved By:

Director Operation Signature Date

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

2. Purpose/Objective:

Installation Qualification is a systematic method to check the basic requirement for the installation of
TABLET COMPRESSION MACHINE. This description includes all important major/ minor components
of installation.

3. Scope:

The scope of activity of installation qualification of TABLET COMPRESSION MACHINE is to ensure that,
i. The installation site is in accordance with the manufacturer recommendations and as per user
requirement.
ii. To perform systematic check of equipment to be installed against the manufactured
specification and establish during design qualification (if performed).
iii. To ensure that all the required utilities are provided according to specification.
iv. To critically check equipment according to predetermined checking criteria (check list).
v. To establish the installation qualification report including observation, deviation encountered
during qualification study and impact of deviation, corrective action to be taken in response of
any deviation and finally the conclusion either it qualifies its installation or not.

4. Responsibilities:

i. Validation Officer
ii. Representative of Engineering Department
5. Installation Qualification Study:

i. To check that machine and accessories are supplied as per purchase order requirement.
ii. To check that the machine is installed at its specified location.
iii. To check that the utilities required by the machine is provided.

6. Documentation:

All documentation work shall be completed concurrently during execution of the qualification. However the
protocol does not define the sequence of the test/ documentation to be carried out.
i. Use indelible black ink for the recording.
ii. Fill out complete information in the format provided.
iii. Do not leave any blank space.
iv. Correct the wrong entry by drawing single line through incorrect data, recording the correct data
and then signing and dating the change.
v. Enter “N/A” in space that is not applicable.
vi. During execution of the protocol any deviation must be implemented as per defined procedure.

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

vii. During protocol execution, report shall be prepared with following details.
 Discussion of all study in observation column
 Qualification is successfully completed or not
 Conclusion
 Recommendation, if any

7. Installation Checklist

S. No. Check Point Yes NO N/A

1 Location of TABLET COMPRESSION MACHINE in Compression Area.

Ensure that the Manual /Booklet which explains the operator instruction,
3
calibration, maintenance and cleaning procedures, is available.
Is the Manual /Booklet having diagram, fabrication, and maintenance & drawing
4
is available?
5 Check the Engineering drawings, parts Diagram. (If applicable)
Check the TABLET COMPRESSION MACHINE for any damage or looseness
6
caused during transportation.
7 Is proper connection of Wires & Cables?

8 Is Power fusing system available?

9 Ensure that the SOP for operating instruction is being prepared.

10 Are Spare Parts available?

11 Is Tool Kit available?

Ensure that the site should not be exposed to direct sunlight or moisture, the
12 room temperature should be more than 30oC and humidity should not be more
than 60%
13 Avoid exposing the Instrument to extreme Electricity fluctuation.
Ensure that the installation surface should be sufficiently large to allow easy work
14 i.e. the space for cleaning operation, calibration and for maintenance should be
sufficiently large.
15 Ensure that the main components of the Instrument are assembled properly.
Ensure that all the supporting utility is provided according to technical
16
requirement.
Ensure that the TABLET COMPRESSION MACHINE is installed in a dry and
17
clean room with good lighting.
The TABLET COMPRESSION MACHINE should be installed on firm and level
18
ground.

19 Ensure whether TABLET COMPRESSION MACHINE properly earthed.

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

8. Machine Description:
 TABLET COMPRESSION MACHINE is a high-tech product which is successfully developed and
designed by adopting advanced technology from abroad and strictly meet GMP requirement.

Ideal For
Tablet Compression
Key Features
 Reasonable structure design
 Requirements of materials to compression technology have been fully satisfied
 The operating parts of mechanical hand completely adopt fully enclosed
 The movement system is allocated with safety clutch, which can effectively realize protection for
fault overload
 Beautiful appearance and easy to be cleaned

Supplied With
 Electric Box
 Hopper
 Frame
 Turret
 Punches and Dies

Technical Specifications:

Operating Speed

Maximum Diameter of Tablet

Maximum Thickness of Tablet

Maximum Depth of Fill

Turret Speed

Production Capacity

Power Supply

Motor

Outline Dimension (L x W x H)

Net Weight

9. Acceptance Criteria:

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00
The TABLET COMPRESSION MACHINE should be installed as per the specifications given by the
manufacturer.

Installation Qualification Report

Equipment Name: Tablet Compression Machine (ZP-31)

Equipment ID: CP/PRD/112

Report Number: IQ-QR-002/09-2023

Department / Location: Tablet Section / Compression Room

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

10. Installation Qualification Report:

Description of Machine: TABLET COMPRESSION MACHINE (ZP-31)

Location of Equipment: Compression Area

Equipment ID: CP/PRD/112

Model / Make: ZP-31 / China

11. Technical Specification:

Operating Speed 1860 Tablets Per Mint (Maximum Capacity)

Maximum Diameter of Tablet 25mm

Maximum Thickness of Tablet 6mm

Maximum Depth of Fill 15mm

Turret Speed 30rpm/mint

Production Capacity 111,600pc/h

Power Supply 380V/3PH/50HZ

Motor 5.5KW

Outline Dimension (L x W x H) 1140 x 1000 x 1690

Net Weight 1850 Kg

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

12. Installation Checklist

S. No. Check Point Yes NO N/A

1 Location of TABLET COMPRESSION MACHINE in Compression Area. Y

Ensure that the Manual /Booklet which explains the operator instruction,
3 Y
calibration, maintenance and cleaning procedures, is available.
Is the Manual /Booklet having diagram, fabrication, and maintenance & drawing
4 Y
is available?
5 Check the Engineering drawings, parts Diagram. (If applicable) N
Check the TABLET COMPRESSION MACHINE for any damage or looseness
6 N
caused during transportation.
7 Is proper connection of Wires & Cables? Y

8 Is Power fusing system available? Y

9 Ensure that the SOP for operating instruction is being prepared. Y

10 Are Spare Parts available? N

11 Is Tool Kit available? Y

Ensure that the site should not be exposed to direct sunlight or moisture, the
12 room temperature should be more than 30oC and humidity should not be more Y
than 60%
13 Avoid exposing the Instrument to extreme Electricity fluctuation. Y
Ensure that the installation surface should be sufficiently large to allow easy work
14 i.e. the space for cleaning operation, calibration and for maintenance should be Y
sufficiently large.
15 Ensure that the main components of the Instrument are assembled properly. Y
Ensure that all the supporting utility is provided according to technical
16 Y
requirement.
Ensure that the TABLET COMPRESSION MACHINE is installed in a dry and
17 Y
clean room with good lighting.
The TABLET COMPRESSION MACHINE should be installed on firm and level
18 Y
ground.

19 Ensure whether TABLET COMPRESSION MACHINE properly earthed. Y

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

13. Facilities:

The Installation Qualification of TABLET COMPRESSION MACHINE was performed in Production

Department of Caraway Pharmaceutical Islamabad - Pakistan.

14. Tool kit supplied with Automatic TABLET COMPRESSION MACHINE:

NO. Category Name Unit Piece

1 Main Machine Set 1
Technical Documents

2 Use Instructions Copy 1

3 Product Certification Copy 1
4 Packing List Copy 1
5
Acceptance form of installation and debugging Copy 1

6 Punches & Dies Set 31

Accessories

7 Hopper Piece 2
9 Tool Box Piece 1
12 Flexible wrench Piece 1
13 Slotted Screwdriver, Philips screwdriver Piece 1 for each
16 Grease gun Piece 1

15. Drawings/Reference Documents:

S. No. Title Documents # Checked by

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

16. Observation / Deviation:

No deviation has been observed during the Installation Qualification of Tablet Compression Machine.

17. Impact of Deviations:

Not Applicable

18. Corrective Action:

Not Applicable

19. Conclusions:

The Installation Qualification Study of Tablet Compression Machine was performed according to
relevant Protocol (IQ-001/09-2023). As no deviation has been encountered during Installation
Qualification. The Tablet Compression Machine fulfills all the required parameters and installation
criteria. The Installation Area is Compression Room Tablet Section.
The change in location or any change in the installation criteria that is mentioned in the Installation
Qualification Protocol (IQ-QR-002/09-2023) of Tablet Compression Machine should be required to
re-qualify (Installation) of the Tablet Compression Machine.

WRAP UP NOTE: From above observations and tests, it is concluded that the
Tablet Compression Machine qualifies its installation and is ready for Operational Qualification.

20. Acceptance Criteria:

The Tablet Compression Machine should be installed as per the specifications given by the
manufacturer.

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 CARAWAY PHARMACEUTICALS
Document Number
CP/QA/QR/055
Installation Qualification Revision Number
00

21. Post Approval:

Prepared By:

Validation Officer Signature Date

Reviewed By:

Production Manager Signature Date

Verified By:

Manager Quality Assurance Signature Date

Approved By:

Director Operation Signature Date

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