Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

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SOP/OS/002 CHECKING PUNCH HEIGH Page 1 of 3

Effective Date Revision Date

CHECKING PUNCH HEIGH

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
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SOP/OS/002 CHECKING PUNCH HEIGH Page 2 of 3

Effective Date Revision Date

1. Purpose
This procedure defines the requirements for checking the punch height used in tablet
compression line for product uniformity and consistency.

2. Scope

This procedure is applicable to tablet production line in Humanwell Pharmaceutical Ethiopia

PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the tablet line leaders to follow the procedure. Quality
assurance manager is responsible for SOP compliance.

5. Material and Equipment

Punches height checking equipment.

6. Procedure
6.1. Take the punch box in spare parts room.
6.2. Clean the punches as per SOP.
6.3. Assemble the punches height checking equipment.
6.4. Clean the platform of punch height checking equipment.
6.5. Place the standard punch (supplied along with equipment) on platform and adjust it
below the dial knob.
6.6. Set dial indicator to zero by rotating the dial of equipment.
6.7. Recheck the zero setting of dial indicator with standard punch and check the height of the
punches by placing it the guide and on to the platform.
6.8. Record the reading of the dial indicator (unit=Inch) on format.
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Document No: Title: Page No.
SOP/OS/002 CHECKING PUNCH HEIGH Page 3 of 3

Effective Date Revision Date

6.9. Similarly check the record the height of all upper and lower punches on the form.
6.10. Discard the punch if the deviation is more than 0.003 inch (in case of round shaped)and
0.005 inch (in case of capsule shaped)than the standard height.
6.11. Hand over the format of the department head after duly checked and signed by
engineering department.
6.12. Clean the platform and dismantle the equipment.
6.13. Keep the equipment parts, dial and standard punch in the wooden box.
6.14. Apply oil on the punch tip before replacing them back into their respective drawers.

7. Abbreviations:
SOP Standard Operating Procedure
8. Related Documents /Applicable document/
None
9. Revision History

Version
Revision Description
No.

1 New