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. 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. 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. 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. References Intellectual Property Rights And Drug
RegulatoryAffairs by Ayesha Parveen ,Sayeeda . Pg .no 119,120
and107-114