Muenster (Germany), 20 November 2009. Two years after founding the company and just 18 months after gaining the accreditation blue inspection body GmbH announced today the successful execution of its 50th GMP audit. Further audit trips to China, India, Israel and various European countries have been scheduled already, meaning that in the first quarter 2010 the 75th audit is targeted to be completed. Blue, as a privately organised inspection body, has thereby set a new benchmark concerning quality and amount of GMP audits for active pharmaceutical ingredients (APIs) in no time at all. The European Directorate for the Quality of Medicines & HealthCare (EDQM) for example, conducted just 28 inspections during 2008.
Blue inspection body GmbH globally examines the Good Manufacturing Practice (GMP) compliant manufacturing of APIs and medicinal products on behalf of pharmaceutical companies. These so called third party audits are used by the pharmaceutical industry to qualify suppliers appropriately, according to regulatory and legal requirements. Nowadays suppliers are usually located outside Europe mostly in Asian countries.
“With the accreditation of GMP audits and the application of quality assurance to third party audits we have broken completely new grounds mid of 2008;” illustrates Dr. Stefan Kettelhoit, managing director of blue inspection body GmbH (www.blue-inspection.com). “At that point in time the proposal for amending the European pharmaceutical directive 2001/83/EC was not published at all and thereby the term accredited was vastly unknown in the field of GMP audits.”
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