Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOH. References1. EFPIA / CEFIC Guideline “Good Manufacturing Practices for Active IngredientManufacturers”, August 19962. EN ISO 9001 Quality systems: “Model for quality assurance in design/development,production, installation and servicing”, July 19943. “Guide to Good Manufacturing Practice for Medicinal Products”, in “The Rulesgoverning Medicinal Products in the European Community“, Volume IV, January 1992.4. Commission Directive of 13 June 1991 laying down the principles and Guidelines ofgood manufacturing practices for medicinal products for human use, (91/356/EEC) -Official Journal of the European Communities; N° L 193 of 17 July 1991.5. Commission Directive of 23 July 1991 laying down the principles and Guidelines of goodmanufacturing practices for veterinary medicinal products (91/412/EEC) - OfficialJournal of the European Communities; N° L 228 of 17 Aug. 1991.6. “Note for Guidance on Stability Testing of Existing Active Substances and RelatedFinished Products” EMEA/CPMP, Draft &3, March 19977. “Guidelines for the Manufacture of Active Pharmaceutical Ingredients (Bulk DrugSubstances)“ published by the Convention for the Mutual Recognition of Inspections inRespect of the Manufacture of Pharmaceutical Products,Document 2/87, (June 1987).8. “Current Good Manufacturing Practices for Finished Pharmaceuticals”, US Food andDrug Administration, 21 CFR Part 211.9. Discussion Draft - Guidance for the Industry - “Manufacture, Processing or Holding ofActive Pharmaceutical Ingredients”U.S. Food and Drug Administration, August 199610. “FDA Guide to Inspection of Validation of Cleaning Processes”, US Food and DrugAdministration; July 1993.76