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The guiding principles of the quality standards of Orion’s entire supply chain are based on full compliance with the EU-regulated good manufacturing and operating practices, efficiency and fluency of processes, product safety and consistent quality and high delivery reliability. By making inspections, Orion ensures that also third parties involved in its supply chain meet these requirements.
Audits conducted by Orion focus strongly on API manufactures, suppliers of raw materials and materials, contract manufacturers, and organisations providing clinical research services to Orion. In 2007 and 2008, Orion conducted a notably high number of inspections and audits in the facilities of API suppliers and contract research organisations to assess their eligibility as contract partners.
Orion has identified only a few critical shortcomings during the audits because agreements are made with partners only if they meet strict selection criteria and because regulatory authorities also ensure their compliance by audits. Audits performed by Orion in 2007−2009 resulted in altogether 6 rejections. |