Schedule t -gmp_(unit-5)

Schedule T– Good Manufacturing Practice of Indian
systems of medicine(AYUSH)
Prepared By:
MOHAMMAD KHALID
(Assistant Professor)
Krishna Pharmacy College, Bijnor (UP)

contents
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
9 April 2020 Krishna Pharmacy College, Bijnor 2

INTRODUCTION
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.

CONTINUE……
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 purview of
G.M.P.

Continue…..
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.
There is also a provision issuance of GMP certificate after
proper inspection of unit.
This GMP certificate has validity for two years from the date
of issuance.

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

Components of GMP
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-I
Factory Premises
General requirements
1. Location and surroundings
2. Buildings
3. Water supply
4. Disposal of waste
5. Containers cleaning

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
Requirements for Sterile product
A. Manufacturing area
B. Precautions against contaminations and mix

PART-II
A.List of machinery, equipment
and minimum manufacturing
premises required for the
manufacture of various
categories of Ayurvedic,
Siddha system of medicines
B. List of machinery, equipment
and minimum manufacturing
premises required for the
manufacture of various
categories of Unani system
of medicine.

GMP Provisions: Under Schedule-T are grouped

Location and surroundings
The factory building for manufacture of
ASU(Ayurveda, Siddha and Unani)
medicines shall be so situated and shall
have such construction as to avoid
contamination from open sewerage, drain,
public lavatory for any factory which
produces disagreeable or obnoxious odour
or fumes or excessive soot, dust and smoke.

Point to be taken into consideration for selection of site for manufacturing
unit
There should be no open sewage, drainage and public lavatory,
factory emitting fumes, excessive soot, dust, smoke, foul smell etc.
in the vicinity to avoid contamination.
Transportation facilities should be available for transportation of
material as well as for workers.
Government incentive such as cash subsidies, tax exemption etc.
Local statutory restrictions.
Availability of suitable quality water.
Available skilled and unskilled personnel.
Availability of maintenance facility
Availability of communication facility
Proximity of facilities like education, housing, recreation, local
transport, shopping etc.

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.

Buildings
The buildings used for factory shall be such
as to permit production of:-
Drugs under hygienic 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.

 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.
 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. There 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.
 working space to allow orderly and logical placement of
equipment and materials to avoid the risk of cross contamination
by other drugs or substances.

Water supply
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.

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

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

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,

Requirements for the sterile products
There should be provision of separate enclosed area specially
designed for sterile products. Salient point for the production of sterile
products are given below:
Manufacturing area
Air lock for entry
Free from dust and ventilated with an air supply
Air supply through bacteria retaining filters (HEPA filter)
Periodical checks of filters and their maintenance record
Area designed to facilitate cleaning and disinfections
Routine microbiological checks.
Restricted entry, procedures for entering and leaving.
Preclude possibility of mix up between non sterile and sterile products

Precautions against contamination and mix
Independent block or isolated enclosure.
Appropriate pressure differential in the process
area.
Suitable exhaust system
Laminar flow sterile air system
Monitoring devices UV lamps etc.
Checking individual containers to ensure
freedom from contamination.
Process controls shall be checked and recorded

store
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.

Continue….
 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.

Continue….
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

Continue….
Packing material stores:
There should be separate space for storage of bottles,
jars, capsule etc. All the containers and closure lids
should be adequately cleaned an dried before packing
the product.
 Finished good product:
The finished product from the production area after
proper packaging should be store in the finished
goods store within an area marked ‘quarantine’ and
subjected for quality control test for conformance to

Continue….
standards , packing and labeling. Only after
the approval of quality control department it
should be moved to finished goods stores
which should be facilitated with proper
shelves and specific storage conditions
required for finished products. Distribution
records should be invariably maintained.

Working space:
 Working space:
Manufacturing area should
be have adequate space and
arrangement to prevent cross
contamination.
 Space requirement for
manufacturing of Ayurveda
and siddha medicine:

Continue….
S. No. Category of medicine Mini. Space required
1 Anjana/Pisti 100 sq. ft.
2 Churna/Nasya, Manjan/Lepa, Kwath Churn 200 sq. ft.
3 Pills/Vatti/Gutika, Matrai 100 sq. ft.
4 Tablets 100 sq. ft.
5 Kupipakva/ksara/Parpati/Lavana, Bhasma,
Satva/Sindura, Karpu
100 sq. ft.
6 Kajal 150 sq. ft.
7 Capsules 100 sq. ft.
8 Ointment/Marham/Param 100 sq. ft.
9 Pak/Avaleh/Khand/Modak/Lakayam 100 sq. ft.
10 Panak, Syrup/pravahi, Kwath, Manapaku 100 sq. ft.
11 Asava/Arishtha 150 sq. ft.
12 Sura 200 sq. ft.
13 Ark Tinir 100 sq. ft.
14 Tail/Ghrit Ney 100 sq. ft.

Space requirement for manufacturing of Unani medicine
S. No. Category of medicine Mini. Space required
1. Itrifla Tiryao/Majoon/laooq/Jawarish Khammiras 100 sq. ft.
2. Arq. 100 sq. ft.
3. Habb (Pills) 100 sq. ft.
4. Sufoof (Powder) 100 sq. ft.
5. Raughan (oils) 100 sq. ft.
6. Shiyaf , Surma, Kajal 100 sq. ft.
7. Mahram, Zimad (Ointment) 100 sq. ft.
8. Qurs (Tablets) 100 sq. ft.
9. Kushta 100 sq. ft.
10. Murabba 100 sq. ft.
11. Capsule 100 sq. ft.
12. Sharbat and Jushnda 100 sq. ft.
13. Qutoor chasm and Marham (Eye drops and eye ointment) 100 sq. ft.

Health & Hygiene:
 Health, Clothing, Sanitation and Hygiene of workers:
• All the workers should be free from contagious disease.
Their uniforms should be suitable to nature of work
climate.
• Clean towel, soap, scrubbing brushes etc. should be
provided to them.
• Their hand should be cover with cloth or synthetic
covering. Stress should be on personal cleaness.
• Provision should be made for separate toilets for men
and women change room and cupboards to keep
cloths/belongings.
• Educational programs on sanittion and personal hygiene
should be conduct for workers to motivate them.

Machinery and Equipments
Machinery and equipments should be according to the size
of operation and nature of product.
Manufacturing process could be manual, semi-automatic or
automatic.
These equipments have to be properly installed and
maintained with proper cleaning. List of equipments and
machinery recommended is indicated in Part II A.
There should be adequate space between machines to
facilitate the cleaning and maintenance operation.
Proper Standard Operational Procedures (SOPs) for
cleaning, maintaining and performance of every machine
should be laid down.

Machinery and equipments for maufacturing of ayurveda and siddha medicine
S. No Category of medicine Machinery and Equipments
1. Anjana/Pisti Kharel-machanized/motorized, kharel, end runner/ball-
mill. Sieves/shifter
2. Churna/Nasya,
Manjan/lepa
Grinder, disintegrator, pulverize, powder mixer,
sieves/shifter
3. Pills/vatti/Gutika, Matirai Ball mill, mass mixer, vati cutting machine, stainless
steel trays/containers for storage
4. Tablets Ball mill, mass mixer/powder mixer granulator, drier,
compressing machine and sugar coating
5. Kupi pkva/kasra/Parpati
/lavana, bhashma, satva/
sidura, karpu/uppu/Param
Bhatti , karahi/stainless steel vessels/patila flask, multani
matti/plaster of paris, coper rod, earthen container, gaj
put bhatti, muffle furnace end/edge runner
6. Kajal Earthen lamps for collection of kajal, tipple roller mill,
end runner, sieves SS patila, feeling/packing and
manufacturing room should be provided with exhaust
fan and ultraviolet lamps.

Continue….
S.No. Category of medicine Machinery and Equipments required
7. Capsule Air conditioner, de-humidiffer, hygrometer, thermometer,
capsule feeling machime
8. Ointments/Marham
pasai
Tube feeling machine, crimping machine/ointments
mixer, end runner / mill
9. Pak/Avaleh/khand/
Modak/lakayam
Bhatti section fitted with exhaust fan and should be fly
proof, iron kadahi/ SS patila and SS storage container
10. Panak, syrup/pravahi,
Kwath, Manapaku
Tincture press, exhaust fan fitted and fly proof, bhatti
section , bottle washing machine, liquid feeling machine,
PP capping machine
11. Asava/Arishtha Same as mentioned above, fermentation tank, containers
and distillation plant where necessary.
12. Sura Same as mentioned above plus distillation plant and
transfer tank
13. Tail , Ghrit, ney Bhatti, kadahi/SS patila SS storage container, filtration
equipment filtration with tap/liquid feeling machine

Batch Manufacturing Records
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 Cosmetics Act, 1940 (23 of 1940.
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 and fire
and specific grindings in terms of internal use.
Documentation and Records

Continue…….
 Batch manufacturing records:
Manufacturing shall maintain the
following record-
I. Each batch manufacturing
record of every machine.
II. List of raw material used,
quality obtained from the store
for production of medicine.
III. Quality control tests (in house
of pharmacopeia tests) such as
tests, color, physical
charecterstics

Distribution records:
• Records of sale and distribution of each batch of
Ayurveda, Siddha and Unai 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 category of Ayurvedic,
siddha and Unani medicines like Bhasma, Rasa,
Kupipakva, Parpati, Sindura, Karpu/uppu/puram,
kushta, Asava-arishta etc. do not have expiry date in
contrast their efficiency increases with the passage of
time. Hence, records need be maintained upto five
years of the exhausting of stock.

Record of Market Complaints
Manufacturers shall maintain a register to record
All reports of market complaints received regarding the products sold
in the market.
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.
Records 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.

References:
https://pharmafranchisehelp.com/drug-cosmetic-act-rules-schedule-tgood-
manufacturing-practice-ayurvedic-sidha-unani/
https://www.slideshare.net/manishagoyal29/gmp-
13558913?from_action=save
https://www.slideshare.net/bharathpharmacist/schedule-t-
39686357?from_action=save
Dr.Sufiyan Ahmad, “Schedule T– Good Manufacturing Practice of Indian
systems of medicine Components of GMP (Schedule–T) and its objectives
Infrastructural requirements, working space, storage area, machinery and
equipments, standard operating procedures, health and hygiene,
documentation and records.”
https://drsufiyan.blogspot.com/2020/02/schedule-t-good-manufacturing-
practice.html?showComment=1586191843781
http://www.authorstream.com/Presentation/vipin99-3628800-herbal-drug-
industry/

Schedule t -gmp_(unit-5)

More Related Content

What's hot

Similar to Schedule t -gmp_(unit-5)

More from Mohammad Khalid

Recently uploaded

Schedule t -gmp_(unit-5)