DRUGS CONTROL ADMINISTRATION

GOVERNMENT OF ANDHRA PRADESH

Inspection Check List
(As per new Schedule M)
Separate comments sheets may by used if space is inadequate

Address of firm

Date of Inspection Name of Licensee

License No.:
/2010
Firm’s representative

Inspected by Telephone No.

Email :

Constitution of the Firm

Purpose of Inspection

Any Certificates held by the firm (ISO,

WHO etc,)

Categories of drugs manufactured

Last two years turn over of the firm

(1) Govt. Supply

(2) Trade

1
1) Location and surroundings

Whether the factory building is so situated and have such

measure to avoid risk of contamination from external
environment including open sewage, drain public laboratory or
any other factory which produces disagreeable obnoxious,
odour, fumes, excessive soot, dust smoke, chemical or
biological emissions.

2.Building and premises

2.1 Whether the building has been designed, constructed and

maintained to suit the manufacturing operations so as to
production of drug under hygienic conditions.

2.2 Whether the building conform to the conditions laid down in the
factories Act,1948.

2.3 Whether the premises used for manufacturing operations and

testing purposes is;

a) compatible with other drug manufacturing operations that

may be carried out in the same or adjacent area

b) Adequately provided with working space to allow orderly

and logical placement of equipment, materials and movement
of personnel so as to avoid possibility of the contamination by
suitable mechanism.

c) Designed/constructed/maintained to prevent entry of insects,

pests, birds, and rodents.
d) whether interior surface of (walls, floors, and ceilings)are
smooth and free from cracks, and permit easy cleaning

e) whether the production and dispensing areas are well lighted

and effectively ventilated, with air control facilities
F) whether the drainage system, is so designed as to prevent
back flow and to prevent insects and rodents entering the
premises
3 Water system

3.1 Whether the unit has validated system for treatment of water
drawn from own or any other source to render it potable in
accordance with standards specified by BIS and water is stored
ensuring freedom from microbial growth.

2
3.2 Whether water tanks are cleaned periodically and
records maintained thereof.

4 Disposal of waste:-

Whether the unit has obtained consent for air and water from
pollution control board.

5 Warehousing area

5.1 Whether adequate areas have been allocated for warehousing of

raw materials, intermediates, packaging material, products in
quarantine, finish products, rejected or returned products.
5.2 Whether the ware housing areas have good storage conditions.
Are they clean and dry and maintained with in acceptable
temperature limits.
5.3 Whether proper rack, bins and platforms have been provided
for the storage.
5.4 Whether receiving and dispatch bays are maintained.

5.5 Whether separate sampling area for active raw materials, and
excipients is maintained
5.6 Whether highly hazardous, poisonous and explosive
materials, narcotics, and psychotropic drugs are stored in safe
and secure areas .
5.7 Whether printed packaging material is stored in safe, separate
and secure areas.
5.8 Whether separate dispensing areas with proper supply of
filtered air and dust control facility are provided for 3-1lactum,
sex hormones and cytotoxic substances or any special category
of product.
5.9 Whether the pest control is done regularly.
6 Production area:-

6.1 Whether the production area has been designed to allow uni-
flow and logical sequence of operations.
6.2 Whether separate and dedicated and self-contained facilities
have been provided for the production of beta lactum,
sex hormones and cytotoxic substances.

3
6.3 Whether service lines are identified by colors for nature of
supply and direction of the flow.

7 Ancillary areas

7.1 Whether rest and refreshment rooms are separate and not
leading directly to the manufacturing and warehouse.

7.2 Whether the ancillary areas are adequate in area as per rules in
every section of production.

8 Quality control area

8.1 Whether separate areas have been provided each for physico
chemical, biological, microbiological and instrumental analysis.

8.2 Whether adequate space have been provided to avoid mix-up

and cross contamination and also suitable storage space for test
samples, returned samples, reference standards, reagents and
records.
8.3 Whether separate AHU”s are provided for biological,
microbiological and radio isotopes testing areas.

9 Personnel:-

9.1 Whether the manufacturing and testing of drug is conducted

under approved technical staff.
9.2 Whether personnel for Quality Assurance has been designated.

9.3 Whether number of personnel employed is adequate and

indirect proportion to the work load.

9.4 Whether the personnel are provided with regular in service

training.
9.5 Name of the technical staff

9.6 Whether head of Q.C is independent of manufacturing unit.

4
10 Health, clothing and sanitation of workers:-

10.1 Whether personnel handling Betalactum antibiotics are

tested for penicillin sensitivity before employment.

10.2 Whether personnel’s in handling if sex hormones, cytotoxic and

other potent drugs are periodically examined for adverse effect.
They should be moved out by rotation.
10.3 Whether all personnel’s have undergone medical examination
including eye examination and all free from Tuberculosis, skin
and other communicable or contagious Diseases and records are
maintained thereof.
10.4 Whether all personnel’s are trained to ensure high level of
personnel hygiene.

10.5 Whether proper uniforms and adequate facilities for personnel

cleanliness such as wash basin and dryers, towels disinfectant
are provided.
11 Manufacturing operations:-

11.1 Whether the contents of all vessels and containers used in

manufacture and storage is conspicuously labeled with the name
of the products, Batch No, Batch Size, and storage of
manufacture along with signature of technical staff.
11.2 Whether products not prepared under asceptic conditions are
free from pathogens.
12 Precautions against mix-up and cross-contamination

12.1 Whether proper AHU, pressure differential segregation, status

labeling have been provided to prevent mix-up and cross
contamination.
12.2 Whether processing of sensitive drugs like beta lactum
Antibiotics and sex hormones is done in segregated areas with
independent AHU and proper pressure differentials along with
demonstration of effective segregation of these areas with
records.

12.3 Whether line clearance is performed according to and

appropriate check list and records.
12.4 Whether packaging lines are independent and are adequately
segregated.

12.5 Whether segregated and secured area is provided for

recalled, rejected and reprocessed materials.

5
13 Sanitation in the manufacturing area

13.1 Whether the premises are cleaned and maintained is an orderly

manner so as to free from accumulated waste, dust and any
other material along with maintenance of a validated cleaning
procedure.
13.2 Whether the manufacturing areas are used as the general
through-fare

13.3 Whether a routine sanitation program has been properly

recorded.

14 Raw materials:-

14.1 whether the records of raw materials are maintained as per

schedule U.

14.2 Whether they are stored in an orderly fashion to permit batch

segregation and stock rotation by a FIFO principle.
14.3 Whether they are labeled and stored as per their status_ Under
test, Approved, and Rejected.

14.4 Whether integrity of the containers of raw materials is intact.

14.5 Whether approved vender list is provided.

15 equipment

15.1 Whether the equipment are designed aiming to minimize risk of

error and permit effective cleaning ir order to avoid cross
contamination, build up of dust and provided with log book
wherever necessary
15.2 Whether balance and other measuring equipments with
appropriate range are available in the raw material stores &
Production areas and they are calibrated in accordance with
SOP maintained.
15.3 Whether the parts of the equipment that come in to contact with
the product are not reactive so as not to affect the quality of the
products.
15.4 Whether the defective equipments are removed from production
areas and properly labeled.
15.5 Check whether lubricants used in the equipment’s contaminate
the products.
16 Documentation and Records
16.1 Whether the documents are prepared and reviewed as per rules
and to provide an audit trail.

6
16.2 Whether the records are made at the time of each operation in
such a way that all significant activities concerning to the
production are traceable. Records and SOPs to be retained at
least one year after the expiry of the finished products during
which all relevant data’s should be radily available.
17 Labels and Other Printed Materials:-
17.1 Whether different colour codes are used to indicate the status of
a product.
17.2 Whether printed packaging materials, product leaflets etc. are
stored separately to avoid chances of mix-up.
17.3 Whether packaging and labeling materials are examined by the
quality control department.
17.4 Whether records of receipt of all labeling and packaging
materials are maintained.
18 Quality assurance:
18.1 Whether the system of quality assurance as ensured that:

(a) The products are designed and developed in accordance with

GMP
(b) The adequate arrangement are made for manufacture,
supply, and use of the correct starting and packaging materials.
(c) Adequate controls on Raw materials and other in process
controls, calibration and validation are carried out
(d) The finished product is correctly processed and checked in
accordance with the established procedures.
(e) Pharmaceuticals products are not released for sale unless
signed and certified by authorized persons as per label claim
19 Self Inspection and Quality Audit:

Whether the firm has constituted a self inspection team

supplemented with a quality Audit procedure to evaluate that
GMP is being followed.
20 Quality control system:

20.1 Whether the unit has its own quality control laboratory with
qualified and experienced staff.

7
20.2 Whether SOP’s are available for sampling, inspecting, testing of
raw materials, finished products and packing materials and also
for Monitoring environmental conditions.
20.3 Whether reference samples from each batch of the products are
maintained.
20.4 Whether all instruments are calibrated and testing procedures
validated before they are adopted for routine testing.

20.5 Whether Pharamacopeias, reference standards working

standards and technical books as required are available.
21 Specifications: are available
21.1 Whether specifications for raw materials, packaging materials,
product containers enclosures, finish products, inprocess and
bulk products, for preparation of containers and closures are
available and is complied with as per rules.
22 Master formulae records
Whether the unit has maintained master formulae records
relating to all manufacturing procedures and batch sizes as
per rules
23 Packaging records:
Whether authorized packaging instructions for each product,
pack size and type are maintained and complied with as per
rules.
24 Batch processing records:
Whether the batch processing records for each products on the
basis and type are maintained and complied with as per rules.
25 Standard operating procedures and records:
Whether SOP’s and records are being maintained and
complied with as per rules. Check whether following SOP’S
are available.
(a) SOP for receipt of materials
(b) SOP for internal labeling, quarantine, storage, packaging
material and other material
(c) SOP for each instrument and equipment

8
 (d) SOP for sampling
(e) SOP for batch numbering
(f) SOP for testing
(g) SOP for equipment assembly and validation
(h) SOP for analytical apparatus and calibration
(j) SOP for training and hygiene for the personnel
(k) SOP for retaining reference sample
(i)sop for handling,re-processing and recoveries
(m)SOP for distribution of the product
26 Validation and Process Validation
Whether validation studies of processing, testing and cleaning
procedures are conducted as per rules
27 Product Recalls:
Whether the prompt and effective recall system of defective
products is being maintained by the unit along with SOP’s for
Recall operations
28 Complaints and adverse reactions:
Whether the unit has maintained review system for
compliments concurring the quality of products along with
Sop’s
29 Site master-File
Whether site master file as per rules have been prepared &
maintained

9
 PART - I B
Specific Requirements for manufacture of Oral Solid Dosage Forms
(Tablets and Capsules)
1
1.2 Whether the unit has
provided effective air
extration systems with
discharge points to avoid
contamination of other
products and process.
Filters to be installed to
retain dust.
1.3 Whether the unit has
taken precaution to
avoid contamination of
fiber shedding materials
like wood
1.5 Whether the unit is
monitoring
environmental
conditions of pressure
differentials
between rooms
1.4 Whether temperature
and humidity is
controlled while
processing of Aspirin,
Ferrous Sulphate,
Effervescent tablets etc.
1.3 Whether metal
detector provided
2
2.1 Whether mixing, sifting
and blending
equipment's are fitted
with dust extractors
unless operated as a
closed system
2.3 Whether critical
operating parameter like
time and temporature for
each mixing and drying
operation are recorded in
BPR

1
0
 2.4 Whether filter bags fitted
to fluid bed drier are
used for different
products without being
washed in between used
2.4 Whether air entering in
to the drier is filtered
3 Compression (Tablets):-
3.1 Whether Tablet
compressing machine
are provided with
effective dust control
facilities and installed
in separate cubicles
3.4 Whether tablets are
being inspected and
checked for suitable
pharmacopial
parameters like
apperance weigh
variation, disintegration,
hardness, friability and
thickness and records
maintained thereof.
3.5& Whether tablets are
3.6 being de-dusted and
monitored for the
presents of foreign
materials and
collected in clean
labeled
containers.
3.4 Whether compressed
tablets are stored
properly
4 Coating (Tablets) :-
4.1 Whether air supplied to
coating pan is filtered
and of suitable quality.
The area should be
provided with suitable
exhaust system and
environmental control
(temparature and
humidity)

1
1
 4.2 Whether coating
solutions be made afresh
and used in a manner to
minimize the risk of
microbial growth
5 Packaging (Strip & Blister)
7.1 Whether rogue tablets
and capsules are
removed before
packaging
7.3 Whether the
strips/Blister coming out
of the machines is
inspected for directs
such as mis-print, outs
on the foil, missing
tablets and improper
sealing
7.4 Whether integrity of
individual packaging
strips is vaccum tested
periodically to ensure
leak proofness
6 Equipments and Area in the Tablet
Section PART-II
TABLET SECTION (GENERAL)
Sl.No. Name Make/Model Number Total Area
of
machin
e

3.1a3 Mass Mixer

3.1a2 Drum Mixer

3.1bi Rotary Tablet Machine

do Rotary Tablet Machine

do Single Stroke Multi
punch Machine

1
2
3.1a5 Hot Air Oven Tray Drier

3.1a5 Fluid Bed Dryer with

thermal heat
3.1a.1 Multi-mill

3.1d2 Coating Pan

3.1d3 Polishing Pan

3.1a.1 Sifter

3.1c.3 Counter Pan

3.1b6 Tablets Disintegration

Machine
3.1b7 Dehumidifier

3.1b6 Physical Balance

do Single Pan Balance

do Hardness Tester
3.1b3 Deduster Machine

Stainless Steal Vessels

Stainless Steal Scoops
3.1b4 Table Inspection Belt

Air Handling Unit

(Specification of filter
and blower capacity)
TABLET SECTION (BETALACTUM) SEPARATE
DESPENSING BOOTH IN THE TABLET SECTION
Sl.No. Name Make/Model Number Total Area
of
machin
e

3.1a3 Mass Mixer

1
3
3.1a2 Drum Mixer

3.1bi Rotary Tablet Machine

3.1a.5 Fluid Bed Dryer

3.1a.1 Multi-mill

3.1a.1 Sifter

3.1b6 Tablets Disintegration

Machine
3.1b7 Dehumidifier

3.1b6 Physical Balance

3.1b4 Tablet Inspection Belt

3.1b3 Deduster Machine

Air Handling Unit

(Specification of filter
and blower capacity)
3.1c.1 Blister Packing Machine

TABLET SECTION (SEX HORMONES) SEPARATE

SAMPLING AND DISPENSING BOOTH
Sl.No. Name Make/Model Number Total Area
of
machine

Roller Compactor
3.1a.2 Drum Mixer

3.1b.1 Rotary Tablet Machine

3.1a.1 Multi-mill

1
4
3.1a.1 Sifter

3.1b.6 Tablets Disintegration

Machine
3.1b.7 Dehumidifier

3.1b.6 Physical Balance

3.1b.6 Single Pan Balance

3.1b.6 Hardness Tester

3.1b.3 Deduster Machine

3.1b.4 Tablet Inspection Belt

Air Handling Unit

(Specification of filter
and blower capacity)
3.1c.1 Blister Packing Machine

7 Equiments and Area in Capsule Section :- PART-II

CAPSULE SECTION (BETALACTUM ANTIBIOTICS)

Sl.No. Name Make/Model Number Total Area

of
machine

5(1) Rota Cube

5(2) Capsule Filling Machine

Sifter
Dehumidifier
Capsule Loading Machine
5(3) Counter Pan

5(4) Physical Balance

1
5
5(6) Capsule Polishing
Machine
Blister Packing Machine
Air Handling Unit
(Specification of filter
and blower capacity)
CAPSULE SECTION (NON BETALACTUM)
Sl.No. Name Make/Model Number Total Area
of
machine

Sifter 25
5.1 Rota Cube Sq.mts.
For basic
5.2 Capsule Filling Machine
installatio
Dehumidifier n And
5.2 Automatic Casule 10
Loading Machine Sq.mts.
5.3 Counter Pan Ancilliar
y area
5.4 Physical Balance
5.2 Semi Atutomatic Capsule
Filling Machine
5.6 Capsule Polishing
Machine
Air Handling Unit
(Specification of filter
and blower capacity)

1
6