Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z
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
Download Schedule M from below Link: