SELF INSPECTION REPORT

Engineering Department :

Report Ref # SI/Engineering /01-2017 :

Date of inspection 10-4-2017 :

Team Leader name: Team member name:

Muhammad Zubair Amir Ghauri

Haji Farrukh Rafi
Jalil ur Rehman
Abdul Jabbar

Distribution list:
AM Engineering
AM Utility
Instrument Officer
AM Compliance
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05

Engineering
Completion
Sr.# Area/Document No. Findings Classification Action Plan/CAPA Responsibility Target Date
Date
SOP N0. ENG-MEC-  Table of contents not  Add table of
001/01 attached. contents. Mr. Abdul
1. Minor
Preventive maintenance of  Form# not attached.  Attach form#. Jabbar
encapsulation machine
SOP NO. ENG- MEC-  Table of contents not  Add table of
002/01 attached. contents. Mr. Abdul
2. Preventive maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
Blister machine
SOP NO. ENG-MEC-  Table of contents not  Add table of
003/01 attached. contents. Mr. Abdul
3. Preventive maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
stripping machine
SOP NO. ENG-MEC-  Table of contents not  Add table of
004/01 attached. contents. Mr. Abdul
4. Preventive maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
Air Compressor ZT_30
SOP N0. ENG-MEC -  Table of contents not  Add table of
005/01 attached. contents. Mr. Abdul
5. Preventive Maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
Pass Box with Conveyer
SOP NO. ENG- MEC -  Table of contents not  Add table of
006/01 attached. contents. Mr. Abdul
6. Preventive maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
Roller compactor
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05
Engineering
Completion
Sr.# Area/Document No. Findings Classification Action Plan/CAPA Responsibility Target Date
Date
SOP NO. ENG-MEC -  Table of contents not  Add table of
007/01 attached. contents. Mr. Abdul
7. Preventive maintenance of  Form# not attached. Minor  Attach form#. Jabbar
ZPT-26 tablet press
machine
SOP NO. ENG-MEC -  Table of contents not  Add table of
008/01 attached. contents. Mr. Abdul
8. Minor
Preventive maintenance of  Form# not attached.  Attach form#. Jabbar
Tablet Coating machine
SOP NO. ENG-MEC -  Table of contents not  Add table of
008/01 attached. contents. Mr. Abdul
9. Preventive maintenance of Minor
 Form# not attached.  Attach form#. Jabbar
Tablet Coating machine
SOP N0. ENG-HVAC-  Table of contents not  Add table of
001/01 attached. contents. Mr. Amir
10. Minor
Operation and Maintenance  Form# not attached.  Attach form#. Ghauri
of Air Handling units
SOP N0. ENG-HVAC -  Table of contents not  Add table of
002/01 attached. contents.
Mr. Amir
11. Operation, inspection and  Form# not attached. Minor  Attach form#.
maintenance of Ghauri
Dehumidifier
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05
Engineering
Completion
Sr.# Area/Document No. Findings Classification Action Plan/CAPA Responsibility Target Date
Date
SOP N0. ENG-HVAC -  Table of contents not  Add table of
003/01 attached. contents.
Mr. Amir
12. Operation and Maintenance  Form# not attached. Minor  Attach form#.
of Absorption Ghauri
Chiller/Pumps
SOP N0. ENG-HVAC -  Table of contents not  Add table of
004/01 attached. contents. Mr. Amir
13. Operation and Maintenance Minor
 Form# not attached.  Attach form#. Ghauri
of Cooling Towers/Pumps
SOP N0. ENG-ELC-01/01  Table of contents not  Add table of
Operation and preventive attached. contents. Mr. Jalil ur
14. maintenance of 750 KVA Minor
 Form# not attached.  Attach form#. Rehman
Generator
SOP NO. ENG-ELC-  Table of contents not  Add table of
002/01 attached. contents.
Mr. Jalil ur
15. Operation and preventive  Form# not attached. Minor  Attach form#.
maintenance of 350 KVA Rehman
Generator
SOP N0. ENG-ELC-003/01  Table of contents not  Add table of
Mr. Jalil ur
16. Use of portable electrical attached. Minor contents.
equipment Rehman
 Form# not attached.  Attach form#.
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05

Engineering
Completion
Sr.# Area/Document No. Findings Classification Action Plan/CAPA Responsibility Target Date
Date
SOP N0. ENG-INST-01/03  Table of contents not  Add table of
Mr. Farrukh
17. Calibration management attached. Minor contents.
Rafi
 Form# not attached.  Attach form#.
SOP NO. ENG-INST-02/03  Table of contents not  Add table of
Calibration of digital attached. contents. Mr. Farrukh
18. temperature indicating Minor
 Form# not attached.  Attach form#. Rafi
controllers
SOP NO. ENG-INST-03/03  Table of contents not  Add table of
Mr. Farrukh
19. Calibration of digital attached. Minor contents.
Rafi
temperature indicator  Form# not attached.  Attach form#.
SOP NO. ENG-INST-04/03  Table of contents not  Add table of
Mr. Farrukh
20. Calibration of flow attached. Minor contents.
switches Rafi
 Form# not attached.  Attach form#.
SOP NO. ENG-INST-05/03  Table of contents not  Add table of
Mr. Farrukh
21. Calibration of Humidity attached. Minor contents.
transmitter Rafi
 Form# not attached.  Attach form#.
SOP N0. ENG-INST-06/02  Table of contents not  Add table of
Use of Standard attached. contents. Mr. Farrukh
22. Minor
Magnehelic Differential  Form# not attached.  Attach form#. Rafi
pressure Gauge
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05

Engineering
Completion
Sr.# Area/Document No. Findings Classification Action Plan/CAPA Responsibility Target Date
Date
SOP NO. ENG-INST-07/03  Table of contents not  Add table of
Mr. Farrukh
23. Calibration of Magnehelic attached. Minor contents.
differential pressure gauges  Rafi
Form# not attached.  Attach form#.
SOP NO. ENG-INST-08/03  Table of contents not  Add table of
Calibration of master attached. contents. Mr. Farrukh
24. instruments (outside Minor
 Form# not attached.  Attach form#. Rafi
source)
SOP NO. ENG-INST-09/03  Table of contents not  Add table of
Mr. Farrukh
25. Calibration of pressure attached. Minor contents.
gauges Rafi
 Form# not attached.  Attach form#.
 CSH Pharmaceuticals (Pvt.) Ltd. Lahore.
SOP No. QA-013/05

Team Signatures
Signature after
Sr.# Name Date Signature after completion Date
Finding

1 Mr. Amir Ghauri

2 Mr. Farrukh Rafi

3 Mr. Jalil ur Rehman

4 Mr. Abdul Jabbar

Department Manager
Sr. # Name: Signature After CAPA Proposal Date Signature After Completion Date
Muhammad Zubair
01
Haji