Schedule

Schedule M: Good Manufacturing Practice

(Last Updated On: March 8, 2018)
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Schedule M:

Schedule M describes Good Manufacturing Practices and Requirements of Premises. 
Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs.
Part 1: Describes Good Manufacturing Practices For Premises and Material

Part 1A: Describes the Specific requirement for manufacture of sterile products. Parenteral preparations (Small Volumn Injections and Large Volumn Parenterals) and Sterile Ophthalmic Preparations

Part 1B: Describes the Specific requirements for manufacture of oral solid forms (Capsule and Teblets)

Part 1C: Describes the Specific Requirements for Manufacture of Oral Liquids (Syrups, Elixirs, Emulsions and Suspensions)


Part 1D: Describes the Specific requirements for Manufacture of Topical Products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
Part 1E: Describes the Specific requirements for manufacture of Metered Dose Inhalers (MDI)

Part 1F: Describes the Specific requirements of premises, plant and material for manufacture of Active Pharmaceutical Ingredients (Bulk Drugs)

Part 2: Describes the Requirements of Plant and Equipment

Schedule M-1:

Schedule M-1 describes the Good Manufacturing Practice requirements of factory premises for manufacture of Homoeopathic preparations:

Schedule M-2:

Schedule M-2 describes the requirements of factory premises for manufacture of cosmetics

Schedule M-3:

Schedule M-3 describes the requirements of factory premises for manufacture of medical devices

(For detail analysis refer drug and cosmetic act and rules)

Full Time Blogger, Part Time Entrepreneur and Partial Time Helper for New Start-UP's in Pharmaceutical, Ayurvedic and Nutraceutical Sector. Contact him at pharmafranchiseehelp@gmail.com

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