Form DOC

Company DOC Audit Report

Class No Survey Report No Page No

Page 1 of 6

This form is an appendix to the applicable forms for ISM

company audits and shall be used for initial, annual, renewal
and pre-audits (for the issuance of DOCUMENT OF
COMPLIANCE)

Ship Management Company  

 
Address:     
 
Contact (Tel):       Contact person:     
 Fax:       
Email:     
 
Date of issue:        Date
of expiry:      

No. Item YES NO NA

1 The raw materials used in the manufacture of both hard and
soft gelatin capsules are properly stored?

- Gelatin is properly stored separately?

2 Raw materials are properly labelled?
- Batch size
- name of material
- packing material
Leakage of any raw materials?
Qualities checking of the incoming material are conducting?
What safety instructions / safety precautions are needed to
define for storage material?
Are the personnel having knowledge of cGMP requirements?
3
Is the warehouse keeping maintained?
Is the weighing balance having proper tag of calibration status?
Is the calibration standard weights available?

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.
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Company DOC Audit Report

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Is there an updated master formula for each product and size of

lot to be manufactured?

4 Do the quality assurance or quality control authorize all master

formulas?
5 Do all products have a master formula containing product
name, code, and product number?
6
Are there adequate changing room before entering the
production area?
Are the procedure available?
Is the area for washing with a supply of purified and filtered
air?
Are the fixed pipes identified and do they indicate the direction
of flow, whenever necessary?
Is the IPC room with calibrated needed instruments?

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.
 Form DOC

Company DOC Audit Report

Class No Survey Report No Page No

Page 3 of 6

7 The production area is properly sanitized and sterilized?

-The room is properly is cleaned?

-Proper HVAC systems are present?
-Air flow systems are present are entry?
-The equipment’s are calibrated?
-Equipment’s are cleaned?
-Capsule filling machines are working as per SOP?
-The manufactured capsules are properly sealed?
-Is the flow of raw material being proper from hopper?
-Precautions are taken to minimize traces of moisture?
-Are the capsules produces exactly per hour?

-The produced capsules are properly sealed?

-The large-scale manufacturing machines are properly calibrated?
The calibration status of equipment’s is recorded with date and
time?
8 The entry and exit of personnel are noted in respective records?

9 The layout of manufacturing area is facilitated for continuous

process?
10 The area is with easy personnel flow?
The filling station and sealing station are proper?
Are the pharmaceutical secondary manufacturing facilities have
been designed based on single rooms or cubicles for each stage of
the manufacturing process?
Are the materials used in formulation added according to
procedure?
The personnel who are handling the production are trained?
The packing of capsules is packed proper?
The quality control tests are performed according to STP?
The results from IPQC and FPQC tests are within the acceptance
criteria?
The obtained results are recorded?

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.
 Form DOC

Company DOC Audit Report

Class No Survey Report No Page No

Page 4 of 6

11 Is the pipeline properly marked with directional arrows?

12 Is logbook of all Equipment properly maintained?
13 Check the condition of reactors.
14 Are all the sampling devices properly stored?
Check the cleaning of sampling devices?
15 Check the finished product packing area.
Check the temperature and humidity record.
16 Check the personnel hygiene.
Check the safety equipment’s.
17 Check the availability and stock of packing materials.
Check the cleaning of sifting area.
Is the BMR requisition slip record available?
Is the calibration certificate available?
18 Is the control copy of Maintenance department SOPs available?
Are equipment’s labeled with last maintenance date and next due
maintenance date?
Check the equipment qualification record?
Check the AHU maintenance record?

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.
 Form DOC

Company DOC Audit Report

Class No Survey Report No Page No

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19 The documentation is recorded with date and signatures?

- Are the documents verified by QA, QC department?
- Are the verified documents properly numbered?
- Any errors in documentation?
- Are the documents are maintained properly for future?
- Is there any line clearance?
- All the logbooks, documents, records, are maintained for
each batch?
- Are the documents are validated?
- Is there any revalidation?
- Are the documents are audited frequently?
- Are the documents are kept securely?
- Are the common technical documents are kept secured?
- Are the packed capsules are stored at appropriate storage
conditions?
- Are the stability and compatibility studies performed?
The packed capsules are given lot number?
Are the packed capsules kept separate from starting materials?

20 Check the AHU’s filter cleaning record.

Check the air velocity of LAF /HEPA filters?
21 Is there check list for each capsule filling equipment for preventive
maintenance?
22 Is the maintenance store area clean?

This is to declare that the undersigned has been examined and

filled all the items of this report before signed it.

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.
 Form DOC

Company DOC Audit Report

Class No Survey Report No Page No

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I have issued an Interim Document of Compliance No.       Valid until

     
I have endorsed the Document of Compliance No.       Valid until
     

I recommend

The issue of a Document of Compliance

No Full term Document of Compliance is to be issued until all
deficiencies in “NON CONFORMITY NOTE” are rectified /
closed.
No Document of Compliance is to be endorsed until all
deficiencies in “NON CONFORMITY NOTE” are rectified /
closed

_________________________________
Name, Signature and Stamp of Surveyor

NOTE: ISClass assumes no responsibility and shall not be liable for any loss, damage directly or indirectly caused by the report in this document.