Schedule L and M - Products and GMP Requirements
Posted: 03 Apr 2021, 15:48
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)
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.
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.