Audit checklist for production area

S.No. Questions Findings Classification

Are there sufficient key personnel to
supervise assigned functions?
1.
Production

Is a complete index and a complete

set of applicable SOPs available in
the
2. Department , Is the set of SOPs
correctly organized, according to the
index ?

Is there gowning SOP for production

3. staff?

Are there written procedures (SOPs)

for cleaning and maintenance of
4. equipment and utensils and are they
followed?

Are cleaning and sanitizing agents

validated and approved for use by
5.
QC?

Master Formula (MF):

Does the MF adequately describe the
6.
complete production process?

Is the MF up-to-date and approved

7. by QC/QA

Are time and temperature limits

established for the completion of
8.
production phases?

Are all deviations from SOPs

documented and subject to review
9. by QA/QC for approval or corrective
action?

Are there SOPs written and

approved for all manufacturing and
10.
testing activities?
 Is there a system for reprocessing of
unsatisfactory and returned products,
11. subject to prior approval by quality
control?

Are there written records of

preparation of cleaning and
12.
sanitizing
solutions?
re there specific procedures for
cleaning of major equipment items?
Do they include instructions as to
13. which parts of the machine require
assemble and disassembly for
cleaning?
Are they followed?
Select a major piece of equipment
Examine the following records:
14.
• Machine Duty Card
• Cleaning Checklist
Examine the record of the daily
check of balances in the department
Is it complete and accurately filled
out
15.
Are all results within the
specifications
If not, is there a record of
implementation of corrective action
Are all work areas clearly labeled
16. with name and batch number of the
product being processed
Are components handled in such a
17.
manner as to prevent contamination
Observe a work station during
production of a batch.
Are manufacturing instructions at
hand?
Are the instructions complete,
18. including special instructions if
relevant?
Are the instructions accurately
followed?
Are records and signatures made on
real time?
Examine the batch record for a batch
19. which is being processed
Product ___________ Batch
 No.___________

Are any in process results within the

20.
defined limits
Is all relevant information included,
complete and accurately filled in as
follows:
Raw Materials Weighing
Manufacturing Method
Yield Reconciliation
21.
In-Process Tests
Packaging Standard
Packaging Control
Laboratory Results
Manufacturing Deviation Report
(MDR), if applicable
Is yield calculation performed after
each distinct phase of production
granulation
22. compression
coating
blistering
Packaging
Is the yield calculation verified by a
23.
second individual
Is there documented evidence of line
24.
clearance where required?
Examine records of air pressure,
temperature and relative humidity
for the
25.
last month. Do they meet the
specifications stated in the relevant
SOP?
Are any deviations recorded together
26. with corrective action taken?
According to the relevant SOP?
Is there an approved annual program
27. for validation of all production
equipment and critical systems?
Whether all personnel prior to
employment have undergone
medical examination including eye
28. examination and all free from
Tuberculosis, skin and other
communicable or contagious
diseases
 Whether proper uniforms and
adequate facilities for personal
cleanliness are provided.
29.
Pls specify nature and type of dress
used by the personnel in
various areas of operation.
What measures has been taken to
prevent mix-ups during various
30.
stages of production.

Is a validation performed to confirm

31. cleaning effectiveness?

Do the flow of cleaned equipment

32. through the washing room don’t
allow re contamination?
Are there gauges to detect pressure
33.
differentials? Is there a record?
Are the walls, floors and ceiling
34.
surfaces smooth and easy to clean?
For fluid bed dryers: is there a set of
sleeves for each product, or is there
35.
a cleaning validation process that
guarantees no cross-contamination?
Is the air injected in the coating
36. equipment filtered? Is it included in
the preventive maintenance plan?
Are the filters used in filtration of
37. liquid disposable? Are the changes
recorded?
Do bottles receive some type of
38. cleaning &on line with before
filling?
Are process controls performed at
39.
each production step?
Are there flow charts showing the
40. production steps and identify critical
points?
Is there a SOP dealing with the use
of proper clothing for other persons
who enter production areas
41.
(technical service/maintenance,
cleaning personnel, quality control
inspectors, quality assurance
 inspectors, and visitors)?

Is the printed information resistant to

42.
fading or erasing?
Is there an area or sector for the
43.
washing of containers and/or tools?
Is the IPC room with calibrated
44.
needed instruments?
Are reprocessing and reworking
previously authorized by
45.
Control/Quality Assurance & done
in accordance with a SOP?