S.no
questions
1
Availability of SOP’s for receiving of raw
materials?
2
Availability of SOP’s for analysis of raw
materials?
3
Are there clearly defined areas for:
 Raw materials
 Printed labels and packs
4
Receiving and dispatch protects raw
materials from the weather:
(reception areas are equipped in such a
way to allow the containers for starting
materials to be cleaned before storage)
5
Method of storage?
6
Raw materials are well packaged in a way
that prevents access of contamination or
foreign particles into the container?
7
Storage information are well documented?
8
is there a quarantine area for raw materials
and active ingredients under test?
9
Are there separated areas for toxic
substances, psychotropic agents, and the
like?
10
Are the areas of adequate size for amount
of materials stored?
Yes
no
N/A
comments
11
Are warehouse lighting and ventilation
adequate?
12
Are the following information mentioned
on the labels?
-Name of material
-Batch number
13
Temperature
readings
are
regularly
checked, recorded, and monitored?
14
Humidity readings are regularly checked,
recorded, and monitored?
15
Has each supplier/vendor of material or
component been inspected/audited for
proper manufacturing controls?
16
Are incoming material and components
quarantined until approved for use?
17
Are materials spaced to allow for cleaning
and inspection?
18
Are labels for different products, strengths,
dosage forms, etc., stored separately with
suitable identification?
19
Is label storage area limited to authorized
personnel?
20
Is the warehouse adequately staffed?
21
Is there a proper supervision?
22
Have the personnel received appropriate
GMP training?
23
Is each delivery visually checked on
receipt for
 General condition?
 Spillage?
24
Is each starting material used only after
release for use?
25
Is there a stock rotation program (FIFO or
FAFO)?
26
Are the discrepancy and justification
documented with an explanation?
27
Are the containers of incoming materials
cleaned before storage?
28
Check the material stock ledger and check
the physical correctness of the material
stock of one material?
29
Check the pest control records?
30
Check the after sampling of every raw
material sampling booth is cleaned?
31
Whether raw material is dispensed only by
designated persons?
32
Is the utensils and equipment used for
dispensing of raw materials cleaned from
all types of extraneous matters?
33
Are the dispensed materials with proper
status labelled?
34
Is there a separate rejection area provided
with lock and key?
35
Is dispensed area supplied with filtered air
& return raiser?
36
Is test certificate obtained with each lot?
37
Are raw materials sources selected based
on quality capability?
38
Is raw material supplier QMS certified?
39
Is FIFO followed?
40
How are raw material quality and quantity
requirements determined?
Audit Number:
Department:
Date(s) of audit:
Auditors:
Scope of Audit:
Type of Audit:
---------------------------------------------------------------------------------------------------------------------------------------------------Executive Summary:
Lead Auditor:
(Sign / Date)
_____________________________________________________________________________
___________________
_____________________________________________________________________________
_____________
Audit Closure Statement:
Head Quality (Sign/Date):
_____________________________________________________________________________
___________________