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PRZOOM - /newswire/ -
Muenster, North Rhine-Westfalia, Germany, 2010/03/08 - In 2010, the pharma service provider Diapharm is going to conduct third-party API audits in Europe, China and India. Medicinal product manufacturers in Europe must audit their API suppliers regularly, either by themselves or through a third-party.
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In 2010, the pharmaceutical service provider Diapharm is again offering worldwide API/GMP audits of API manufacturing sites with a focus on Europe, China and India. Diapharm made this announcement on the occasion of the DIA Annual Euro Meeting in Monaco. During these trips, different active pharmaceutical ingredients (APIs) from different customers are audited for GMP compliance, grouped together by API manufacturing site and region. This audit sharing is extremely cost-efficient. “With these accredited third-party audits, we enable pharmaceutical companies to control their API production at the highest level,” explains Martin Vortkamp, who is in charge of the shared audit service at Diapharm. “The confidentiality interests of all participating companies have always highest priority.”
Pharmaceutical companies in Europe are obliged to guarantee the quality of their APIs used for the production of medicinal products. In order to do this, they must periodically audit their suppliers according to Good Manufacturing Practice (GMP). The growing number of CEP suspensions and revocations shows the urgency of these inspections. “Since we established this business with accredited audits in 2008, Diapharm (diapharm.com) has already audited over 50 APIs – from Alfuzosin from the Czech Republic to Venlafaxine from India,” says Martin Vortkamp. Usually the audits are performed by our partner the blue inspection body GmbH, an independent (Type A inspection body) Third-Party-Audit provider accredited according to ISO/IEC 17020 for the 'inspection of excipients and active pharmaceutical ingredient manufacturers for pharmaceutical products'. The audit reports are normally available for sale to other interested companies as well.
Additional information about planned audit trips in 2010 is available from Karin Müller, Diapharm GmbH
T: +49 (0)251 60935-511
E: karin.mueller[.]diapharm.com.
The full list of audit reports is available online.
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