Factory Premises:
The manufacturing plant should have adequate space for:-
(i) Receiving and storing raw material.
- Manufacturing process Areas
- Quality control section.
- Finished goods store
- Office
- Rejected goods/drugs store
1.2 General Requirements:
1.1(A) Location and surroundings:
The factory buildings for manufacture of Ayurveda, Siddha and Unani
medicines shall be so situated and shall have such construction as to
avoid contamination from open sewrage, drain, public lavatory or any
factory which produces disagreeable or obnoxious odour or fumes or
excessive soot, dust or smoke.
1.1(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. It should have adequate provision of light and
ventilation. The floor and the walls should not be damp or moist. The
premises used for manufacturing, processing, packaging and labeling
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 of omission of any manufacturing or control step:
(III) Designed, constructed and maintained to prevent entry of
insects and rodents. 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 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.
(IV) Provided with proper drainage system in the processing area.
The sanitary fitting and electrical fixtures in the manufacturing area
shall be proper and safe.
(V) Furnace/Bhatti section could be covered with tin roof &
proper ventilation, but sufficient care should be taken to prevent
flies and dust.
(VI) There should be fire safety measures and proper exits should be
there.
1.1(C) Water Supply:
The water used in manufacture shall be pure and of potable quality.
Adequate provision of water for washing the premises shall be made.
1.1(D) Disposal of Waste:
From the manufacturing sections and laboratories the waste water &
the residues which might be prejudicial to the workers or public
health shall be disposed off after suitable treatment as per
guidelines of pollution control authorities to render them harmless.
1.1(E) Container’s Cleaning:
In factories where operations involving the use of containers such
as bottles, vials and jars are conducted, there shall be adequate
arrangements separated from the manufacturing operations for washing,
cleaning and drying of such containers.
1.1(F) Stores:
Storage should have proper ventilation and shall be free from
dampness. It should provide independent adequate space for storage of
different types of material, such as raw material, packaging material
& finished products.
1.1(F)(A) Raw Materials:
All raw materials procured for manufacturing will be stored in the
raw materials store. The manufacture based on the experience and the
characteristics of the particular raw material used in Ayurveda,
Siddha and Unani system shall decide the use of appropriate containers
which would protect quality of the raw material as well as prevent it
from damage due to dampness, microbiological contamination or rodent
and insect infestation, etc. If certain raw materials require such
controlled environmental conditions, the raw materials stores may be
sub-divided with proper enclosures to provide such conditions by
suitable cabinization. While designing such containers, cabins or
areas in the raw materials store, care may be taken to handle the
following different categories of raw material:-
- Raw material of metallic origin.
- Raw material of mineral origin.
- Raw material from animal source.
- Fresh Herbs.
- Dry Herbs or plant parts.
- Excipients etc.
- Volatile oils/perfumes & flavours.
- Plant extracts 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 `UNDER TEST’ or `APPROVED’ or `REJECTED’.
The labels shall further indicate the identify of the particular
supply in the form of batch No. or lot No. and the date of receipt of
the consignment.
All the raw materials shall be sampled and got tested either by the
in house Ayurvedic, Siddha and Unani experts (Quality control
technical person) or by the laboratories approved by the Government
and shall be used only on approval after verifying. The rejected raw
material should be removed from other raw material store and should be
kept in separate room. Procedure of `First in first out should be
adopted for raw materials wherever necessary. Records of the receipt,
testing and approval or rejection and use of raw material shall be
maintained.
1.1(F)(B) Packaging Materials:
All packaging materials such as bottles, jars, capsules etc. shall
be stored properly. All containers and closure shall be adequately
cleaned and dried before packing the products.
1.1(F)(C) Finished Goods Stores:
The finished goods transferred from the production area after proper
packaging shall be stored in the finished goods stores within an area
marked "Quarantine". After the quality control laboratory
and the experts have checked the correctness of finished goods with
reference to its packing/labeling as well as the finished product
quality as prescribed, then it will be moved to "Approved
Finished Goods Stock" area. Only approved finished goods shall be
dispatched as per marketing requirements. Distribution records shall
be maintained as required.
If any Ayurvedic, Siddha and Unani drug needs special storage
conditions, finished goods store shall provide necessary environmental
requirements.
1.1.(G) Working space:
The manufacturing area shall provide adequate space (manufacture and
quality control) for orderly placement of equipment and material used
in any of the operations for which these are employed so as to
facilitate easy and safe working and to minimize or to eliminate any
risk of mix-up between different drugs, raw materials and to prevent
the possibility of cross contamination of one drug by another drug
that is manufactured, stored or handled in the same premises.
1.1(H) Health Clothing, Sanitation and Hygiene of Workers:
All workers employed in the Factory shall be free from contagious
diseases. The clothing of the workers shall consist of proper uniform
suitable to the nature of work and the climate and shall be clean. The
uniform shall also include cloth or synthetic covering for hands, feet
and head wherever required. Adequate facilities for personal
cleanliness such as clean towels, soap and scrubbing brushes shall be
provided. Separate provision shall be made for lavatories to be used
by men and women, and such lavatories shall be located at places
separated from the processing rooms. Workers will also be provided
facilities for changing their clothes and to keep their personal
belongings.
1.1(I) Medical Services:
The Manufacturer shall also provide:-
(c) adequate facilities for first aid;
(d) 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.
1.1(J) Equipment:
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, labeling and packing etc. To ensure ease in
movement of workers and orderliness in operations a suitably adequate
space will be ensured between two machines or rows of machines. These
Equipments have to be properly installed and maintained with proper
cleaning. Proper standard operational procedures (SOPs) for cleaning,
maintaining & performance of every machine should be laid down.
1.1(K) Batch Manufacturing Records:
The licencee shall maintain batch manufacturing record 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 the store, tests conducted during the various stages of
manufacture like taste, colour, 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 the
Drugs and Cosmetic Act, 1940 (23 of 1940). These tests may include any
in-house or pharmacopoeial test adopted by the manufacturer in the raw
material or in the process material and in the finished product. These
records shall be duly signed by Production and Quality Control
Personnel respectively. Details of transfer of manufactured drug to
the finished products store including dates and quantity of drugs
transferred along with record of testing of the finished product, if
any, and packaging, records shall be maintained. Only after the
manufactured drugs have been verified and accepted quality shall be
allowed to be cleared for sale.It should be essential to maintain the
record of date, manpower, machine and equipments used and to keep in
process record of various shodhana, Bhavana, burning in fire and
specific grindings in terms of internal use.
1.1(L) Distribution Records:
Records of sale and distribution of each batch of Ayurveda, Siddha
and Unani Drugs shall be maintained in order to facilitate prompt and
complete recall of the batch, if necessary.
1.1(M) Record of Market Complaints:
Manufacturers 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. The Register shall also be
available for inspection during any inspection of the premises.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. The manufacturer shall investigate any of the
adverse reaction to find if the same is due to any defect in the
product, and whether such reactions are already reported in the
literature or it is a new observation.
1.1(N) Quality Control:
Every licensee is required to provide facility for quality control
section in his own premises or through Government approved testing
laboratory. The test shall be as per the Ayurveda, Siddha and Unani
pharmacopoeial standard. Where the tests are not available, the test
should be performed according to the manufacturers specification or
other information available. The quality control section shall verify
all the raw materials, monitor in process, quality checks and control
the quality of finished product being released to finished goods
store/ware house. Preferably for such Quality control there will be a
separate expert. The quality control section shall have the following
facilities:
- There should be 150 sq. feet area for quality control section.
- For identification of raw drugs, reference books and reference
samples should be maintained.
- Manufacturing record should be maintained for the various
processes.
- To verify the finished products, controlled samples of finished
products of each batch will be kept for 3 years.
- To supervise and monitor adequacy of conditions under which raw
materials, semi-finished products and finished products are stored.
- Keep record in establishing shelf life and storage requirements
for the drugs.
- Manufacturers who are manufacturing patent proprietory Ayuveda
Siddha, and Unani medicines shall provide their own specification
and control references in respect of such formulated drugs.
- The record of specific method and procedure of preparation, that
is, "Bhavana", "Mardana" and "Puta"
and the record of every process carried out by the manufacturer
shall be maintained.
- The standards for identity, purity and strength as given in
respective pharmacopoeias of Ayurveda, Siddha and Unani systems of
medicines published by Government of India shall be complied with.
- All raw materials will be monitored for fungal, bacterial
contamination with a view to minimise such contamination.
- Quality control section will have a minimum of
- 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.
- 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 manufacture of sterile Ayurvedic, Unani and Siddha drugs,
separate enclosed areas specifically designed for the purpose shall be
provided. These areas shall be provided with air locks for entry and
shall be essentially dust free and ventilated with an air supply. For
all areas where aseptic manufacture has to be carried out, air supply
shall be filtered through bacteria retaining filters (HEPA Filters)
and shall be at a pressure higher than in the adjacent areas. The
filters shall be checked for performance on installation and
periodically thereafter the record of checks shall be maintained. All
the surfaces in sterile manufacturing areas shall be designed to
facilitate cleaning and disinfection. For sterile manufacturing
routine microbial counts of all Ayurvedic, Siddha and Unani drug
manufacturing areas shall be carried out during operations. Results of
such count shall be checked against established in-house standards and
record maintained.
Access to manufacturing areas shall be restricted to minimum number
of authorised personnel. Special procedure to be followed for entering
and leaving the manufacturing areas shall be written down and
displayed.
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. In case
of terminally sterilised products, the design of the areas shall
preclude the possibility of mix up between non-sterile and sterile
products.
(B) Precautions against contamination and mix:
- Carrying out manufacturing operations in a separate block of
adequately isolated building or operating in an isolated enclosure
within the building.
- Using appropriate pressure differential in the process area.
- Providing a suitable exhaust system.
- Designing laminar flow sterile air systems for sterile products.
- The germicidal efficiency of UV lamps shall be checked and
recorded indicating the burning hours or checked using intensity.
- 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.
- Expert technical staff approved by the Licensing Authority shall
check and compare actual yield against theoretical yield before
final distribution of the batch.
All process controls as required under master formula including room
temperature relative humidity, volume filled, leakage and clarity
shall be checked and recorded.
