Difference Between Schedule M, M1, M2, M3 GMP, Drugs & Cosmetics Act

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Schedule M, M1, M2, M3 are parts of Drugs And Cosmetics Act. Schedule M to M3 Contains Good manufacturing requirements for Drugs. This are formulated to ensure that Drugs intended for human consumption and diagnosis have required safety and efficacy.

Lets see the difference between different GMP related schedules of Drugs And Cosmetics Act.

Schedule M

Schedule M is titled “Good Manufacturing Practices And Requirements Of Premises, Plant And Equipment For Pharmaceutical Products”.

The GMP requirements in schedule M are for Pharmaceutical Products. It specify GMP requirements for premises such as buildings, air conditioning, waste management, sanitation of workers, record keeping, etc for pharmaceutical products.

Its Parts 1 A deals with the specific requirements for sterile products, parenteral preparations and sterile ophthalmic preparations.

Part 1 B has specific requirements for manufacture of oral solid dosage forms. ( Tablets And Capsules)

Part 1 C has specific requirements for the manufacture of oral liquids. (Syrup, Elixirs, Emulsions And Suspensions)

Part 1 D Specific requirements for manufacture of topical products , i.e. External preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products)

Part 1 E Specific requirements for manufacture of metered-dose-inhalers (mdi)

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

Schedule M1 is titled “Good Manufacturing Practices And Requirements Of Premises, Plant And Equipment For Homoeopathic Medicines”.

Complete Schedule M:  Schedule M In Drugs and Cosmetics Rules, For GMP In Pharmaceuticals

Schedule M-1

Schedule M- 1 is titled “Good Manufacturing Practices And Requirements Of Premises, Plant And Equipment For Homoeopathic Medicines”.

The GMP requirements in schedule M1 are for Homeopathic Products. It specify GMP requirements for premises such as buildings, ventilation, waste management,  quality control etc for Homeopathic medicines.

Schedule M1 prescribe basic equipment and facilities for different sections such as potentiation section, container section, lotions section, opthalmic preparation section etc.

Complete Schedule M1: Schedule M1 GMP In Homeopathic Medicines, Drugs And Cosmetics Act

Schedule M-2

Schedule M- 2 is titled “Requirements Of Factory Premises For Manufacture Of Cosmetics”.

The GMP requirements in schedule M2 are for Cosmetic Products. It specify GMP requirements for premises such as buildings,  equipments, basic sanitation etc for cosmetic products.

Schedule M2 prescribe basic equipment and facilities for different sections such as creams, nail polishes, lipstics, hair dyes and powders etc.

Complete Schedule M2: Schedule M-2 GMP For Cosmetics, Drugs And Cosmetics Act

Schedule M-3

Schedule M- 3 is titled “Quality Management System –For Notified Medical Devices And In-Vitro Diagnostics”.

The GMP requirements in schedule M3 are for notified medical devices. It specify GMP requirements for premises such as buildings,  equipment, design and development validation, record keeping etc for medial devices and diagnostic products. Schedule M3 also has Annexures from A to C.

Complete Schedule M3: Schedule M3 GMP Medical Devices And Diagnostics, Drugs And Cosmetics Act

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