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SOP REF # TEC – 001B APPENDIX – 5

Internal Audit checklist


Area: Administration Department Date: 6 / 9 / 2017 page 1 of 2
S # Question / audit point. Findings / Comments Compliance
Comply /
not Comply
1- Is there any source of There is no source of environmental contamination in Comply
environmental contamination the area surrounding the factory; the company located
in the area surrounding the in a residential and agricultural area, fuel station beside
building? the factory has been built after the company. No
hazard affect on the company, no smoke or other
things arises that contaminate the area of the company;
the company has an air handling unit.
2- Are the drained equipped to Yes, the drained designed to prevent flow back and Comply
prevent back flow? there is no evidence of back flow happened. Checked
the deviation and complaint reports, no deviation
raised about flow back drained, no complaint or note
from MOH about this situation.
3- Does the company comply The company provided by a fire alarm system, and Comply
with the cGMP requirement of there are many of fire extinguisher in each department,
fire control and prevention? checked the fire extinguisher of administration
department the label of last check for fire extinguisher
is 20 -7- 2017 , in RM Warehouse for Normal
products , the last check was 5 – 8 – 2017 , in Syrup
department the last check for fire extinguisher in 1- 7 –
2017 the company comply with cGMP requirement ,
4- How the companies dispose the Waste is disposed of by sending by trucks to landfills, Comply
waste? Is it as per as per sop's of laboratory waste disposed off (
requirements? ADMIN- 001B , and disposal of waste in ( ADMIN-
003A )
5- Is there a program of control Yes there is a program, and there is SOP, checked the Comply
for rodent and insects? reports, last record was in 15 / 6 / 2017, the next in 15 /
9 / 2017.
6- Is there a written procedure Any person suspected of having an infection or illness Not
clarify the procedure of dealing or any person who informed the administration about Comply
with person who has an his illness is sent to Abu-Ghraib hospital as (referral)
apparent illness? for examination, and
If the result of the examination is positive, he will be
given a leave for a day or two depending on his
situation, but this is not mention in the sop
SOP REF # TEC – 001B APPENDIX – 5
Internal Audit checklist
Area: Administration Department Date: 6 / 9 / 2017 page 2 of 2
S# Question / audit point. Findings / Comments Compliance
Comply / not
Comply
7- Are all people entrant to production There is a medical examination for Not Comply
area have a medical examination report workers as per SOP # ADMIN -006,
they send for examination on yearly
basis, and new workers should be
checked before employment to ensure
that they are free from contagious
diseases. There is no check to all
people how enter production area like
heads, supervisors, IPC and
technicians
8- If the medical examination perform take - Yes Checked the reports of Comply
an example of some employees employees medical examination ,
date of examinations :
1- , pencillin dept. – 5 – 1 – 2017
2- - pencillin dept. 9 – 8 – 2017
3-– tap. Dept. 8 -1 – 2017
4-– Syrup dept. 5- 8 – 2017
5-– R. M. warehouse – 4 – 1 - 2017
9- Is there a procedure clarify the entering No standard operating procedure for Not Comply
to production area by workers? gowning of workers only some
instruction for visitors.

10- Is there an emergency exits in the There is no emergency exits in the Comply
building, are maintained and building , but there are 4 doors used
unobstructed? for entering and exiting and these
doors use as alternate emergency exits
11- Is there a separate canteen area, is it Yes there is a separate canteen area, Comply
neat and clean? and we check it, it’s neat and clean.

Auditor Auditor Auditor QA Manager

Name: Farhan Name: Name: Name:

Sign : Sign : Sign : Sign :

Date : Date : Date : Date :

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