Schedule T – Good Manufacturing Practice of Indian system of medicine
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 partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required | ||
| Churna | 200 sq feet | Grinder/disintegrator/Pulveriser/ Powder mixer/sieves/shifter |
| Capsules | 100 sq feet | AC, De-humidifier, hygrometer, thermometer, Capsule filling machine and chemical balance |
| Asava / Arista | 200 sq. ft | Fermentation tanks, containers and distillation plant where necessary, Filter Press |
| Taila | 100 sq. ft | Bhatti, Kadahi/S.S. Patila S.S.Storage Containers, Filtration equipment, filling tank with tap/Liquid filling machine |
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, partitions for each activity. If Ayurveda / Siddha Medicines are also manufactured in same premises an additional area of 400 square feet will be required | ||
| 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 machine, Bottle drier, Bhatti |
| 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
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