Schedule m new

1. “ SCHEDULE M” (Good manufacturing practice) Presented by T.N.Kalyani 256213886027 Malla Reddy College Of Pharmacy Guided by A.Rajareddy M.Pharm ( Ph.D )

2. HISTORY The basic responsibility of a manufacturer is to ensure the production of quality products . These quality objectives can be achieved by GMP and hence they were implemented as Schedule M in 1988. The Schedule M has again been ammended in amajor way by the drugs and cosmetics act (8 th ammendment ) rules,2001 and embraces 71,74,76 and 78 under drugs and cosmetics 1995.

3. Schedule “M” Requirement of factory premises ,plant and equipment for manufacturing drugs and pharmaceutical products. M-1 : R equirement of factory premises for the manufacture of homeopathic preparations. M-2 : Requirement of factory premises for the manufacture of cosmetics. M-3 :Requirement of factory premises for the manufacture of medical devices

4. Part 1 -GMP for premises and materials Part 1-A : Specific requirements for the manufacture of sterile products,parentaral preparations and sterile opthalmic preparations . Part 1-B: Specific requirements for the manufacture of oral solid dosage forms (tablets and capsules) . Part 1-c: Specific requirements for the manufacture of oral liquids (syrups, emulsions, suspensions,elixirs,etc ) .

5. Part 1-D: Specific requirements for the manufacture of topical products. Part 1-E: Specific requirements for the manufacture of metered dose inhalers. Part 1-F: Specific requirement of premises,plant and materials for the manufacture of active pharmaceutical ingredients (bulk drugs) . Part 2: Requirements of plant and equipment.

6. References Intellectual Property Rights And Drug Regulatory Affairs by Ayesha Parveen , Sayeeda . Pg .no 119,120 and 107-114