Discuss in detail about various parts of schedule M as per Drugs & cosmetics act.

It is defined as "the part of quality assurance which is aimed to ensure that the product are consistently manufactured to the quality appropriate to their intended use."  

Schedule M has Different parts discussed bellow:

M GMP requirements of factory premises, plant and equipment for manufacturing drugs and pharmaceutical products.

PART- I GMP for Premises and Materials 

  • PART - I-A : Specific Requirements for the manufacture of Sterile products. Parenteral products and Sterile ophthalmic preparations. 
  • PART - I-B : Specific Requirements for the manufacture of Oral solid dosage form (Tablet & Capsule). 
  • PART - I-C : Specific Requirements for the manufacture of Liquid Orals (Syrup, Elixirs, Suspensions, emulsions) 
  • PART - I-D : Specific Requirements for the manufacture of Topical Products (Creams) 
  • PART - I-E : Specific Requirements for the manufacture of Metered Dose Inhalers (MDIs) 
  • PART - I-F: Specific Requirements of Premises, plant and equipments for the manufacture of APIs. 
PART - II : Requirments for Plant and Equipments.

M-I : Requirements of premises plant and equipment for the homeopathy preparations.

M-II: Requirements of premises plant and equipment for the manufacture of cosmetics.

M-III:  Recruitments of factory premises for the manufacture of medical devices.

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