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Schedule L Drugs

Schedule L:- Omitted

Schedule L (I) :- Good Laboratory Practices and requirements of premises and equipment, Chemicals & Reagents, etc

Schedule M Drugs

This Schedule includes Good Manufacturing Practices and requirements of premises, plant and equipment for manufacture of pharmaceutical products.

Part 1:- Good Manufacturing Practices for premises and materials

1A- Specific requirements for manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenterals) and steri ophthalmic preparations.

1B- Oral solid dosage forms (tablets and capsules)

1C- Oral liquids (syrups, elixirs, emulsions and suspensions)

1D- Topical products (creams, ointments, pastes, emulsions, lotions, etc.)

1E- Metered-dose-inhalers (mdi)

1F- Specific requirements of premises, plant and materials for manufacture of active pharmaceutial ingredients (bulk drugs)

Part 2:- Requirements of Plant and equipment

Good Manufacturing Practices (GMP)

  • Location and surroundings- Free from open sewage,public lavatory, dust, smoke, excessive soot, obnoxious odour, chemical or biological emission
  • Buildings and premises- Designs suitable for manufacturing operation and maintain hygiene.
  • Water system- Validated system for water treatment to make it usable and free from microbial growth.
  • Disposal of wastes- Disposal shall be according to Environment Pollution Control Board and as per provision.
  • Warehousing area- Designs allow sufficient and orderly warehousing of various categories of materials and products.
  • Production area-Area shall be designed to allow the production preferably in uni-flow with logical sequence of operation and avoiding the risk of cross contamination.
  • Quality control area- Lab independent of production area with separate and adequate space for each type of testing.
  • Manufacturing operation-All operations shall be carried out under supervision of technical staff approved by Licensing Authority.
  • Documentation and record- It shall specify the title, nature and purpose and laid out in orderly fashion.

Schedule M- I:- Prescribes in detail requirements of factory premises for the manufacture of Homeopathic drugs.

Schedule M- II:- Prescribes requirements of factory premises for manufacture of cosmetics.

Schedule M- III:- Prescribes requirements of factory premises for manufacture of medical devices.
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