Schedule t

SCHEDULE T
GOOD MANUFACTURING PRACTICES FOR
AYURVEDIC
SIDDHA AND UNANI MEDICINES
S.SWATHI
M.PHARMACY(I/II)
PHARMACOGNOSY

The Good Manufacturing Practices are
prescribed to ensure that
I. Raw materials used in the manufacture of drugs are
authentic, of prescribed quality and are free from
contamination
II. The manufacturing process is as has been prescribed to
maintain the standards.
III. Adequate quality control measures are adopted.
IV. The manufactured drug which is released for sale is of
acceptable quality
V. To achieve the objectives above each licensee shall
evolve methodology and procedures for following the
prescribed process of manufacture of drugs which
should be documented as a manual and kept for
reference and inspection.

PART I
Good Manufacturing Practices

1. Factory Premises
 The manufacturing plant should have adequate
space for:
I. Receiving and storing raw material.
II. Manufacturing process areas.
III. Quality control section.
IV. Finished goods store.
V. Office.
VI. Rejected goods/drugs store.

2. General Requirements
A. Location and surroundings
B. Buildings
The building used for factory shall be such as to
permit production of drugs under hygenic conditions
and should be free from cobwebs and insects/rodents.
The premises used for manufacturing, processing,
packaging and labelling will be in conformity with
the provisions of the Factory Act. It shall be located
so as to be:

I. Compatible with other manufacturing operations that
may be carried out in the same or adjacent premises.
II. Adequately provided with working space to allow
orderly and logical placement of equipment and
materials to avoid the risk of mix up between different
drugs or components thereof and control the possibility
of cross contamination by other drugs or substances
and avoid the risk or omission of manufacturing or
control step.

III. Designed, constructed and maintained to prevent entry of
insects and rodents.
IV. Interior surface (walls, floors and ceilings) shall be
smooth and free from cracks and permit easy cleaning
and disinfection. The walls of the room in which the
manufacturing operations are carried out shall be
impervious to and to and be capable of being kept clean.
The flooring shall be smooth and even and shall be such
as not to permit retention or accumulation of dust or
waste products.

C. Water Supply
D. Disposal of Waste
E. Container’s cleaning
F. Stores
(F-A) Raw Materials
All raw materials procured for manufacturing shall be
stored in the raw materials store.
While designing such containers, cabins or areas in the
raw materials store, care may be taken to handle the

Following different categories of raw materials
1. Raw material of metallic origin.
2. Raw material of mineral origin.
3. Raw material from animal source.
4. Fresh Herbs.
5. Dry Herbs or plant parts.
6. Excipients etc.
7. Volatile oils/perfumes and flavours.

8. Plant concentrates and exudates/resins.
Each container used for raw material storage shall be
properly identified with the label which indicates name
of the raw material, source of supply and will also
clearly state the status of raw material such as
‘UNDERTEST’ or ‘APPROVED’ or ‘REJECTED’.
The labels shall further indicate and identify the
particular supply in the form of batch No. or lot No.
and the date of receipt of the consignment.

(F-B) Packaging Materials
(F-C) Finished Goods Stores
The finished goods transferred from the production
area after proper packaging shall be stored in the
finished goods stores with in an area marked
“Quarentine”. After the quality control laboratory and
the expects have checked the correctness of finished
goods with reference to its packing/labelling as well as
finished product quality as prescribed then it will be
moved to “Approved Finished Goods Stock” area.

G. Working space
H. Health Clothing Sanitation and Hygiene of Workers.
I. Medical Services
The manufacturer shall also provide-
(a) Adequate facilities for first aid;
(b) Medical examination of workers at the time of employment
and periodical check up thereafter by a physician once a
year, with particular attention being devoted to freedom
from infections. Records thereof shall be maintained.

J. Machinery and Equipments
For carrying out manufacturing depending on the size
of operation and the nature of product manufactured,
suitable equipment either manually operated or
operated semi-automatically (electrical or steam based)
or fully automatic machinery shall be made available.
These may include machines for use in the process of
manufacture such as crushing, grinding, powdering,
boiling, mashing, burning, roasting, filtering, drying,
filling, labelling and packing etc.

K. Batch Manufacturing Records
The license shall maintain batch manufacturing records of each
batch of ayurvedic, Siddha and Unani drugs manufactured
irrespective of the type of product manufactured (classical
preparation or patent and proprietary medicines).
Manufacturing records are required to provide an account of
the list of raw materials and their quantities obtained from
physical characteristics and chemical tests as may be necessary
or indicated in the approved books of Ayurveda, Siddha and
Unani mentioned in the First Schedule of Drugs and Cosmetics
Act.1940 .

L. Distribution Records
M. Record of Market Complaints
Manufactures shall maintain a register to record all reports of market
complaints received regarding the products sold in the market. The
manufacturer shall enter all data received on such market complaints,
investigations carried out by the manufacturers regarding the complaint as
well as any corrective action initiated to prevent recurrence of such market
complaints shall also be recorded. Once in a period of six months the
manufacturer shall submit the record of such complaints to the licensing
authority.
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha
and Unani drugs shall also be maintained in a separate register by each
manufacturer.

N. Quality Control
Preferably for such quality control, there should be a
separate expert. The quality control section shall have
the following facilities:
1. There should be 150sq. Feet area for quality control
section
2. For identification of raw drugs, reference books and
reference samples should be maintained.
3. Manufacturing record should be maintained for the
various processes.

4. To verify the finished products, controlled samples of
finished products of each batch will be kept for 3 years.
5. To supervise and monitor adequacy of conditions
under which raw materials, semi-finished products and
finished products are stored.
6. Keep record in established shelf life and storage
requirements for the drugs.
7. Manufactures who are manufacturing patent,
proprietary Ayurveda, Sidda and Unani medicines shall
provide their own specification and control references
in respect of such formulated drugs.

9. The standards for identity, purity and strength as given
in respective pharmacopeias of Ayurveda, Siddha and
Unani systems of medicines published by Government
of India shall be complied with.
10. All raw materials will be monitored for fungal,
bacterial contamination with a view to minimise such
contamination.

11. Quality control section will have a minimum of
a) One person with Degree qualification in
Ayurveda/Siddha/unani(A.S.U) as per Schedule II of indian
Medicine Central Council Act, 1970 (84 of 1970) of a
recognized university or Board.
b) Provided that Bachelor of Pharmacy, Pharmacognosy and
Chemistry may be associated with the quality control section.

Requirement for sterile product
A. Manufacturing Areas
For the manufacturing of Ayurvedic, Siddha and Unani drug
that can be sterilised in their final containers,the design
of the areas shall preclude the possibility of the
products intended for sterilisation being mixed with or
taken to be products already sterilised. Incase of
terminally sterilised products, the design of the areas
shall preclude the possibility of mix up between
nonsterile and sterile products.

Requirement for sterile product
B. Precaution against the contamination and mix
a. Carrying out manufacturing operation in a separate block of
adequately isolated building or operating in an isolated
enclosure within the building.
b. Using appropriate pressure differential in process area.
c. Providing a suitable exhaust system.
d. Designing laminar flow sterile air system for sterile products.
e. The germicidal efficiency of UV lamps shall be checked and
recorded indicating the burning hours or checked using
intensity.

f. Individual containers of liquids, and opthalmic
solutions shall be examined against black-white
background fitted with diffused light after filling to
ensure freedom from contamination with foreign
suspended matter.
g. Expert technical staff approved by the Licensing
Authority shall check and compare actual yield against
theoretical yield before final distribution of the batch.

PART-II
A. List of machinery, equipment and minimum manufacturing premises required for the
manufacture of various categories of ayurvedic, siddha system medicines
Sr.No Category of
Medicine
Minimum
manufacturing space
required
Machinery/equipment
recommended
1200 Square feet covered
area with separate cabins
partitions for each activity. If
Unani medicine are
manufactured in same
premises an additional Area
of 400 sq. feet will be
required.
1. Churna / Nasya /
Manjan/ Lepa
Kwath Chum
200 Sq. feet Grinder/Disintegrator/Pulverisa
r/Powder mixer/Sieves/shifter
2. Pills/Vatti/Gutika
Matirai
100 Sq. feet Ball Mill, Mass mixer/power mixer,
pill/vati cuttin machine, stainless
steel trays/Containers for Storage.
Driers/ Machanised chatee (for
mixing quggul) where required.

3 Tablets 100 Sq. feet Ball Mill, Mass Mixer/Powder
mixer, Granulator drier, Tablet
compressing Machine and
sugarcoating, foliching pay in
case of sugar coated tablets,
mechanised chatte (for mixing
of guggulu) where required.
4 Kajal 100 Sq. feet Karthen lamps for Collection of
Kajal, Tipple Roller Mill, End
Runner, Sieves, S.S Patila,
Filling/packing manufacturing
room should be provided with
exhaust fan and ultra violet
lamps.
5 Capsules 100 Sq. feet Air-Conditioner, De humidifier,
hygrometer, Thermometer,
Capsule filling Machine and
chemical balance.

6 Ointment/Marham
Pasai
100 Sq. feet Tube filling machine, Crimping
Medicine/Ointment Mixer, End
Runner/Mill (Where required),
S.S Patila.
7 Asava/Aristha 100 Sq. feet 200 Sq. feet
8 Each
manufacturing unit
will have a
separate area for
Bhatti, furnaces,
boilers, puta, etc.
This will have
proper ventilation,
removal of smoke,
prevention of flies,
insects, dust etc.
the furnace section
could have tin roof.

B. List of machinery, equipment and minimum manufacturing premises required for the
manufacture of various categories of Unani System of Medicines
Sr.No Category of
Medicine
Minimum
manufacturing space
required
Machinery/equipment
recommended
1200 Square feet covered
area with separate cabins
partitions for each activity. If
Ayurveda/Siddha medicines
are manufactured in same
premises an additional Area
of 400 sq. feet will be
required.
1 Habb (Pills) and
Tablets
100 sq. ft Ball Mill, Mass Mixer Powder
mixer, Granulator drier, tablet
compressing machine, pill/vati
cutting machine, staineless steel
trays/container for storage and
sugar coating, polishing pan in
case of sugar coated tablets,
mechanised chatoo, (for mixing of
guggul) where required.

2 Sufoof (Powder) 200 sq. ft. Grinder/Pulveriser, Seiver,
Trays, Scoups, Powder mixer,
(where required).
3 Raughan (Oils)
(Crushing and
Boiling)
100 sq. ft. Oil Expeller, S.S. Patilas Oil
filter bottle filling machine,
bottle drier, Bhatti.
4 Marham, Zimad
(Ointment)
100 sq. ft. Kharal, Bhatti, End runner,
Grinder, Pulversiser, Tripple
Roller Mill.
5 Qurs (Tab) 100 sq. ft. Grinder/Pulveriser,
Sieves,power mixer (where
needed),Granulator, Drier,
Tablet compressing machine,
Die punches Trays, O.T.
Apparatus, Balance with
weights, Scoops, Sugar
coating pan, Polishing pan,
Heater.

6 Capsule 100 sq. ft. Pulveriser, Powder mixer
(where needed), capsule
filling machine, Air
conditioner, De-humidifier
balance with weights, storage
containers, glass.
7 Qutoor-e-Chashm and Marham (Eye
drops, eye ointment)
100 sq. ft. Hot air oven electrically
heated with Thermostatic
control, kettle.
8 Each manufacturing unit will have a
separate area for Bhatti, furnaces,
boilers, putta etc. This will have
proper ventilation, removal of smoke,
prevention of flies, insects,dust etc.

C. LIST OF EQUIPMENT RECOMMENDED FOR IN HOUSE QUALITY
CONTROL SECTION.
(Alternatively unit can get the testing done from the Government approved laboratory).
A CHEMISTRY SECTION (B) PHARMACOGNOSY SECTION
1. Alcohol Determination Apparatus
(complete set).
1. Microscope Binocular.
2. Volatile Oil Determination
Apparatus.
2. Dissecting Microscope
3. Boiling Point Determination
Apparatus.
3. Microtome
4. Melting Point Determination
Apparatus.
4. Physical Balance
5. Refractometer. 5. Aluminium Slide trays.
6 Polarimeter. 6. Stage Micrometer.
7. Viscometer. 7. Camera Lucida (Prism and
Mirror Type).

8. Tablet Disintegration Apparatus. 8. Chemicals, Glass-ware etc.
9. Moisture Meter
10. Muffle Furnace
11. Electronic Balance
12. Magnetic Stirrer.
13. Hot Air Oven
14. Refrigerator.
15. Glass/Steel Distillation
Apparatus

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