Quality Management System for Active pharmaceutical
Quality Management System for Active pharmaceutical
Quality Management System for Active pharmaceutical
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<strong>Quality</strong> <strong>Management</strong> <strong>System</strong> - integrating GMP into ISO11. “Guide to Inspection of Bulk Pharmaceutical Chemicals“, US Food and DrugAdministration, Revised Edition, May 1994.12. “Concepts <strong>for</strong> the Process Validation of Bulk Pharmaceutical Chemicals“ edited by thePharmaceutical Manufacturers Association, QC Section, Bulk PharmaceuticalsCommittee, in Pharmaceutical Technology Europe, January 1994.13. “Good Manufacturing Practices <strong>for</strong> active <strong>pharmaceutical</strong> ingredients (bulk drugsubstances)” in WHO Expert Committee on “Specifications <strong>for</strong> PharmaceuticalPreparations, 32 nd Report“, Geneva, 1992, ISB 92 4 1208236.14. “Good Manufacturing Practices <strong>for</strong> Pharmaceutical Products, Annex - Guidelines on theValidation of Manufacturing Processes”, WHO / Pharm /93.562 / rev 2.15. “Good Manufacturing Practices Guide <strong>for</strong> Bulk Pharmaceutical Excipients“, TheInternational Pharmaceutical Excipients Council, October 1995.77
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