Good Manufacturing Practices
of Ayurveda
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. |