This slides contain description about SCHEDULE T good manufacturing process of Indian system of medicine contains about the process of GMP in indian system of medicine...

1. SCHEDULE T
GOOD MANUFACTURING OF
INDIAN SYSTEM OF MEDICINE
PREPARED BY
PRANJAL SAXENA
B.PHARMA 6TH SEM.
ORIENTAL UNIVERSITY

2. INTRODUCTION:-
SCHEDULE T
Schedule T: (Schedule T describes the Good Manufacturing Practice
for Ayurvedic, Siddha and Unani Medicines.)
The Good Manufacturing Practices (GMP) are prescribed as follows:
Raw materials used in the manufacture of drugs are authentic, of
prescribed quality and are free from contamination.
The manufacturing process is as has been prescribed to maintain
the standards.
Adequate quality control measures are adopted.
The manufactured drug which is released for sale is of acceptable
quality.

3. CONTINUED......
To achieve the objectives listed 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. However, under IMCC Act 1970 registered Vaidyas,
Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not
selling such drugs in the market are exempted from the preview of G.M.P.
In India GMP was introduced under schedule-M as an amendment to Drugs and Cosmetics rules
1945 in 24.06.1988.
Then after this Schedule was further elaborated in 23 june 2000 which specific the GMP features
to be followed for ISM (Indian System of Medicine) drugs.
Teaching institutes and registered qualified Vaidyas, Siddhars and Hakeems who prepare
medicines on their own to dispense to their patients and not selling such drugs in the markets are
exempted from the purview of schedule-T.

4. OBJECTIVE OF GMP
1.
2.
3.
Implementation of GMP ensures total quality assurance covering all the spheres in
a manufacturing system
These are highlighted below-
Raw material and Finished products- Their authenticity, quality, freedom from
foreign matter and contaminant.
Manufacturing process confirms to prescribed quality standards. Adoption
adequate quality control measures.
Documentation- Methodologies and procedures for reference and inspection.

5. COMPONENTS OF GMP
1.
2.
3.
4.
5.
GMP schedule for ISM manufacturing units is quite elaborate and broadly covers each and every
component of manufacturing process.
Different components of GMP are given below in order of appearance in Schedule-T :-
•PART 1 Factory Premises
General requirements
Location and surroundings
Buildings
Water supply
Osalposal of waste
Containers cleaning

6. CONTINUE......
6. Stores (Raw materials, Packing material, Finished Goods Stores)
7. Working space
8. Health, Clothing Sanitation and Hygiene of Workers
9. Medical Services
10. Equipment’s
11.Batch manufacturing Record
12. Distribution Record
13.Record of market complaints
14. Quality control

7. 1.
2.
Requirements for Sterile product
A. Manufacturing area
B. Precautions against contaminations and mix
PART 2
List of machinery, equipment and minimum manufacturing premises required for
the manufacture of various categories of Ayurvedic, Siddha system of medicines
List of machinery, equipment and minimum manufacturing premises required for
the manufacture of various categories of Unani system of medicine.

8. GMP PROVISION
UNDER SCHEDULE
T

9. FACTORY PREMISES
Factory premises should have adequate space for following different
activities . Receiving and storing raw material
• Manufacturing process areas
• Quality control section
. Finished goods store
• Office
• Rejected goods/drugs store.

10. BUILDING
1.
2.
3.
4.
5.
6.
The buildings used for factory shall be such as to permit production of:-
Drugs under hygienic conditions and should be free from and insects/rodents.
It should have adequate provision of light and ventilation.
The floor and the walls should not be damp or moist.
working space to allow orderly and logical placement of equipment and materials to avoid the
risk of cross contamination by other drugs or substances.
It is 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.

11. The sanitary fittings and electrical fixtures in the manufacturing area shall be proper and safe.
Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient
care should be taken to prevent flies and dust. T
here should be fire safety measures and proper exits should be there.
Drying Space: - There should be separate space for drying of raw materials, in process
medicine or medicines require drying before packing.
This space will be protected from flies/ insects/ dust etc., by proper flooring, wire mesh
window, glass panels or other material.

12. WATER SUPPLY
1.
2.
3.
Water used in manufacturing should be pure and of potable quality.
Adequate provision for washing of premises should be made.
Potable water should conform to prescribed standards (ICMR standards) Ion-
exchange treatment and distillation plants may be installed for the availability
of purified water and water for injection respectively.
Following periodicals schedules for monitoring the quality of water is required
to ensure the quality of water used in the manufacturing unit.

13. CONTAINERS CLEANING
There provision independent area for
cleaning of containers adequate
arrangement for washing, cleaning and
drying (bottles, vials, jars, etc. used for
packing of various dosage forms)
should be made. should be for of
containers

14. From the manufacturing
section and laboratories the
waste water and the
residues which might
prejudicial to the workers or
public be health shall be
disposed off.

15. CONTINUE........
Waste water and residue should be disposed only after suitable treatment as per the guidelines
of pollution control authorities following important legislation enforced by in this regard should
also be consulted.
Air (Prevention and control of pollution) act 1981
The environment (protection) Act 1986 & 1975
The water (prevention & control of pollution) act 1974 & 1975
Manufacture, storage & Import of Hazardous chemicals Rules 1989.
Hazardous waste(Management and Handling) Rules 1989 etc.
Central Pollution Control Board & State Pollution Control Board,

16. STORES:-
1.
2.
Raw material stores:
• For the storage of raw material appropriates containers as per materials
(physical and chemical properties) may be used to prevent from dampness,
microbiological contamination, rodent and insects infection.
• In ISM manufacturing unit raw material may be categorized as follows for
their appropriate storage:-
Fresh herbs e.g. Mint, Basil
Dry herbs e.g. Parsley, Rosemary Plant extracts and exudates/resins etc.

17. Volatile oils/perfumes and flavors e.g. Peppermint, Clove, Caraway
Animal origin e.g. Honey, Royal jelly, Beeswax.
Metallic origin e.g. Cu, Cr, Mn, Zn, Pb.
Mineral origin e.g. Clays, Bentonite, Aggregates, Kaolin
Excipients e.g. colorants, sweeteners, binders, diluents.
Each container should be properly labeled and informative in following format:
Name of raw material
Source of supply Status- Under test/ Approved/ Rejected
• Batch/Lot no.
Date of receipt

18. WORKING SPACE AND SANITIZATION OF
WORKERS:-
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 er 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.
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.

19. MEDICAL SERVICES AND MACHINERY AND
EQUIPMENT:-
The manufacturer shall also provide:
(O Adequate facilities for first aid; m Medical examination of workers at the time of
employment and periodical checkup thereafter by a physician once a year, with particular
attention being devoted to freedom from infections: Records thereof shall be maintained.
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 team based) or fully automatic machinery shall be
made available. These may include machines for use in the process of manufacture such
crushing, grinding, powdering, boiling, mashing. burning, roasting, filtering, drying, filling, Iabelling
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.

20. BATCH MANUFACTURING RECORD
The licensee shall maintain batch manufacturing record of each batch of
Ayurvedic, Siddha and Unani drugs manufactured irespective of the type
of product manufactured (classical preparation or patent and proprietary
medicines). Manufacturing records are required to provide and account
of the list of raw materials and their quantities obtained from the store,
tests conducted during the various stages ofmanufacture like taste,
colour, physical characteristics and chemical tests as may be necessary
or indicated in the approved books of Ayurveda, Siddha and Unani .

21. DISTRIBUTION AND COMPLAINT 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. The duration of record keeping
should be the date of expiry of the batch, Certain categories of Ayurvedic, Siddha and Unani medicines
like Bhasma, Rasa, Kupi- pakva, Parpati, Sindura, Karpu/Uppu/Puram, Kushta, Asava-arista, ete. do not
have expiry date, in contrast their efficacy increases with the passage of time. Hence, records need to be
maintained up to 5 years of the exhausting of stock.
Manufacturers shall maintain a register to record all reports of market complaints received regárding 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 such complaints to the Licensing Authority.

22. THANK YOU