Professional Documents
Culture Documents
Version: 01
GENERAL INFORMATION
Address of the manufacturing unit Plot No.- 94/B, Survey No.-104/A/1, Pappdy Ind.Estate,
Village:Dhowli,Vasai(West), Dist. Palghar , Maharashtra -401201.
List of Directors/Partners/Proprietor
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
2. Ancillary Areas
2.1. Sch-M Specify the position of rest and refreshment Rest and refreshment room is near office
rooms and mention whether they are ground floor separated and not leading
separated and not leading directly to the directly to the manufacturing and warehouse
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
2.2. Sch-M Specify whether primary clean garments are Primary clean garments with S.S.COB &
provided for each personnel entering the S.S. cabinet, slipper at men & ladies Change
factory premises. room
2.3. Sch-M Specify whether change room facilities are
provided separately for Male and Female Male and Female staff change room facilities
staff including Visitor's change room are provided, no Visitor's change room
2.4. Sch-M Specify whether maintenance workshop is Maintenance workshop separated and away
separated and away from production. from production area should provided at
ground floor
3. Water and Compressed Air System
3.1. Sch-M Verify whether a current drawing of the water
system showing all equipment in the system
from inlet to the points of use is available.
3.2. Sch-M Specify the Material of Construction (MOC)
of the purified water storage tank and its pipe
line.
3.3. Sch-M Specify whether water system
validation/qualification has been carried out
as per protocol and reports have been
prepared and maintained.
3.4. Sch-M Specify source of raw water and give details
of treatment processes, sampling points,
distribution and storage system for raw and
purified water.
3.5. Sch-M Verify whether the Raw Water holding tank
was sanitised as per specified SOP.
3.6. Sch-M Specify whether the quality of potable water
used for the preparation of purified water
meets the requirement of Schedule M
3.7. Sch-M Specify how water tanks are cleaned
periodically and records maintained thereof.
3.8. Sch-M Specify the system in place for the
compressed gases / air used in the facility.
4. Disposal of Waste
4.1. Sch-M Specify the system of disposal of sewage and
effluents (solid, liquid, and gas) from the
manufacturing site.(Enclose the copy of NOC
obtained from State Pollution control board in
this regard.)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
9.3. Sch-M Specify how service lines are identified for nature
of supply and direction of the flow.
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
20.3. Sch-M Whether the formats, Logs & SOPs are available
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
a) Personnel.
b) Premises including personnel facilities.
c) Maintenance of buildings and equipment.
d) Storage of starting materials and finished
products.
e) Equipments.
f) Production and in process controls.
g) Quality control.
h) Documentation.
i) Sanitation and hygiene.
j) Validation and re- validation program.
k) Calibration of instruments or measuring
systems.
l) Recall procedures.
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
LIST OF ABBREVIATIONS
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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
GUIDANCE INSPECTION CHECKLIST FOR GRANT OF MANUFACTURING LICENCES
(FOR NON-STERILE DRUG PRODUCTS)
**End of Document**
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