1. 1. SCHEDULE M(Good manufacturing practice)Presented byT.N.Kalyani256213886027Malla Reddy College OfPharmacyGuided byA.RajareddyM.Pharm (Ph.D)
2. 2. HISTORY The basic responsibility of a manufacturer is toensure the production of quality products . These quality objectives can be achieved by GMPand hence they were implemented as Schedule M in1988. The Schedule M has again been ammended inamajor way by the drugs and cosmetics act (8thammendment) rules,2001 and embraces 71,74,76and 78 under drugs and cosmetics 1995.
3. 3. Schedule MRequirement of factory premises ,plant andequipment for manufacturing drugs andpharmaceutical products. M-1: Requirement of factory premises for themanufacture of homeopathic preparations. M-2: Requirement of factory premises for themanufacture of cosmetics. M-3:Requirement of factory premises for themanufacture of medical devices
4. 4. Part 1-GMP for premises and materials Part 1-A : Specific requirements for the manufacture ofsterile products,parentaral preparations and sterileopthalmic preparations . Part 1-B: Specific requirements for the manufacture oforal solid dosage forms (tablets and capsules) . Part 1-c: Specific requirements for the manufacture oforal liquids (syrups, emulsions,suspensions,elixirs,etc) .
5. 5. Part 1-D: Specific requirements for the manufacture oftopical products. Part 1-E: Specific requirements for the manufacture ofmetered dose inhalers. Part 1-F: Specific requirement of premises,plant andmaterials for the manufacture of active pharmaceuticalingredients (bulk drugs) . Part 2: Requirements of plant and equipment.
6. 6. References Intellectual Property Rights And Drug RegulatoryAffairs by Ayesha Parveen ,Sayeeda . Pg .no 119,120 and107-114