Schedule T
– Good Manufacturing Practice of Indian system of medicine
Content
• Objectives of GMP
• Aspects of GMP
Objective
At the
end of this lecture, student will be able to
• Describe the objectives of GMP
• Discuss the various aspects
of GMP
GMP (Schedule – T) objectives and its components
Objectives
Ø Raw
materials used in the manufacture of drugs are authentic, of prescribed quality
and are free from contamination
Ø The
manufacturing process is as has been prescribed to maintain the standards
Ø Adequate
quality control measures are adopted
Ø The
manufactured drug which is released for sale is of acceptable quality
Ø To
achieve the objectives, 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
Ø 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
GMP – Factory premises
The manufacturing plant should have adequate space for
Ø Receiving
and storing raw material
Ø Manufacturing
process areas
Ø Quality
control section
Ø Finished
goods store
Ø Office
Ø Rejected
goods/drugs store
GMP – General requirements
Location and surroundings
Ø Shall
be so situated and shall have such construction as to avoid contamination from
open sewerage, drain, public lavatory or any factory which produces
disagreeable or obnoxious odour or fumes or excessive soot, dust or smoke
Buildings
Ø Permit
production of drugs under hygienic conditions
Ø Free
from cobwebs and insects/rodents
Ø Adequate
provision of light and ventilation
Ø Floor
and the walls should not be damp or moist
Ø Conformity
with the provisions of the Factory Act
Water Supply
Ø The
water used in manufacture shall be pure and of potable quality
Ø Adequate
provision of water for washing the premises shall be made
Disposal of Waste
Ø Waste
water and the residues shall be disposed off after suitable treatment as per guidelines
of pollution control authorities
Containers’ Cleaning
Ø Adequate
arrangement for washing, cleaning and drying of containers such as glass
bottles, vials and jars should be provided
Stores
Ø Should
have proper ventilation and shall be free from dampness
Ø Should
provide independent adequate space for storage of different types of material,
such as raw material, packaging material and finished products
Raw Materials
Ø Raw
materials procured shall be stored in the raw materials store
Ø Appropriate
containers to protect the quality of the raw material as well as prevent it
from damage due to dampness, microbiological contamination or rodent and insect
infestation shall be used
Raw Materials
Ø While
designing containers, cabins or areas in the raw materials store, care may be
taken to handle the following different categories of raw materials
• Raw
material of metallic origin
• Raw
material of mineral origin
• Raw
material from animal source
• Fresh
Herbs
• Dry
Herbs or plant parts
• Volatile
oils/perfumes & flavours
• Plant
concentrates/extracts and exudates/resins
Raw Materials
Ø Status
of raw material such as ‘UNDER TEST’ or ‘APPROVED’ or ‘REJECTED’
Ø Batch No. or Lot. No. and the date of receipt
of consignment
Ø Rejected
raw material should be removed from other raw materials
Ø Store
Ø Procedure
of ‘First in first out’ should be adopted for raw materials
Ø Records
of the receipt, testing and approval or rejection and use of raw material shall
be maintained
Packaging Materials
Ø All
packaging materials such as bottles, jars, capsules, etc. shall be stored
properly
Ø All
containers and closures shall be adequately cleaned and dried before packing
the products
Finished Goods Stores
Ø Finished
goods transferred from the production area after proper packaging shall be
stored in the finished goods stores within an area marked “Quarantine”
Ø “Approved
Finished Goods Stock” area
Finished Goods Stores
Ø “Approved
Finished Goods Stock” area
Ø Only approved finished goods shall be
dispatched
Ø Distribution
records shall be maintained
Working Space
Ø Provide
adequate space (manufacture and quality control) for orderly placement of
equipment and material used
Health, Clothing, Sanitation and Hygiene of Workers
Ø Workers
employed in the factory shall be free from contagious diseases
Ø Clothing
of the workers shall consist of proper uniform suitable to the nature of work
and the climate and shall be clean
Ø Uniform
shall also include cloth or synthetic covering for hands, feet and head
wherever required
Ø Adequate
facilities for personal cleanliness such as clean towels, soap and scrubbing
brushes shall be provided
Ø Separate
provision shall be made for lavatories to be used by men and women
Medical Services
Ø The
manufacturer shall also provide
Ø Adequate
facilities for first aid;
Ø Medical
examination of workers at the time of employment and periodical check
Machinery and Equipments
Ø Suitable
equipment either manually operated or operated semi-automatically or fully
automatic machinery shall be made available
Ø Machines
for crushing, grinding, powdering, boiling, mashing, burning,
roasting,filtering, drying, filling, labeling and packing, etc
Machinery and Equipments
Ø Adequate
space shall be provided to ensure
between two machines or rows of machines for the workers to move freely
Ø Proper
standard operational procedures (SOPs) for cleaning maintaining and performance
of every machine should be maintained
Batch Manufacturing Records
Ø Shall
maintain batch manufacturing record of each batch
Ø Shall
be duly signed by Production and Quality Control Personnel
Distribution Records
Ø Records
of sale and distribution of each batch of shall be maintained
Ø Duration
of record keeping should be the date of expiry of the batch
Ø In
some cases, records need to be maintained up to 5 years of the exhausting of
stock
Record of Market Complaints
Ø Manufacturers
shall maintain a register to record
Ø Once
in a period of six months the manufacturer shall submit the record such
complaints to the Licensing Authority
Ø Reports
of any adverse reactions shall also be maintained
List of recommended machinery, equipment and minimum
manufacturing premises required for the manufacture of various categories of
ayurvedic, siddha system of medicines
|
Category of Medicine |
Minimum manufacturing space required |
Machinery/equipment recommended |
|
1200 Square feet covered area with separate cabins or |
||
|
Churna |
200 sq feet |
Grinder/disintegrator/Pulveriser/ Powder mixer/sieves/shifter |
|
Capsules |
100 sq feet |
AC, De-humidifier, hygrometer, thermometer, Capsule |
|
Asava / Arista |
200 sq. ft |
Fermentation tanks, containers and distillation plant where necessary, Filter |
|
Taila |
100 sq. ft |
Bhatti, Kadahi/S.S. Patila S.S.Storage Containers, |
List of machinery, equipment and minimum manufacturing
premises required for the manufacture of various categories of unani system of
medicines
|
Category of Medicine |
Minimum manufacturing space required |
Machinery/equipment recommended |
|
1200 square feet covered area with separate cabins, |
||
|
Sufoof (Powder) |
200 sq. feet |
Grinder / pulveriser, Sieves, Trays, Scoops, Powder mixer |
|
Raughan (oils) (Crushing and boiling) |
100 sq. feet |
Oil Expeller, S.S. Patilas Oil filter bottle, Filling |
|
Shiyaf, Surma, Kajal |
100 sq. feet |
End runner, mixing S.S. Vessel |
|
Kushta |
100 sq. feet. |
Bhatti, Kharal, Sil Batta, Earthen pots |
List of equipment recommended for in-house quality control
section
Chemistry section
Ø Alcohol
Determination Apparatus
Ø Volatile
Oil Determination Apparatus
Ø Boiling
Point Determination Apparatus
Ø Melting
Point Determination Apparatus
Ø Refractometer
Ø Polarimeter
Ø Stage
Micrometer
Ø Viscometer
Ø Tablet Disintegration Apparatus
Ø Chemicals, Glassware etc
Ø Moisture
Meter
Ø Muffle
Furnace
Ø Electronic
Balance
Ø Magnetic
Stirrer
Ø Hot
air oven
Ø Refrigerator
Ø Glass/Steel
Distillation Apparatus.
Ø LPG
Gas Cylinders with Burners
Ø Water
Bath
Ø Heating
Mantles/ Hot Plates
Ø TLC
Apparatus with all accessories (Manual)
Ø Paper
Chromatography apparatus with accessories
Ø Sieve
size 10 to120 with Sieve shaker
Ø Centrifuge
Machine
Ø Dehumidifier
Ø pH
Meter
Ø Limit
Test Apparatus
Pharmacognosy section
Ø Microscope
Binoculor
Ø Dissecting
Microscope
Ø Microtome
Ø Physical
Balance
Ø Aluminium
Slide Trays
Ø Stage
Micrometer
Ø Camera
Lucida
Ø Chemicals, Glassware etc
Summary
• GMP principles – Must be
built into manufacturing process
• Prevents
errors that cannot be eliminated through quality control of finished product
• Ensures
all units of a medicine are of the same (within specified parameters) quality
• Poor
medicines leads to loss of credibility for everyone: manufacturers, health care workers and
governments