Worwag gets accreditation for generic clopidogrel and losartan

Germany's Worwag R&D, specialized in the development of medicinal products, has for the first time sought certification of Good  Manufacturing Practices for two new generics by an external accredited  auditor. The blue inspection body GmbH served as an independent  third-party auditor for the GMP compliant manufacturing of clopidogrel  and losartan. The company is the first accredited,  commercially-organized inspection body for active pharmaceutical  ingredients in Europe.

"With the external quality assessment of blue inspection body we obtain  an additional competitive advantage for our new medicinal products for  prophylaxis of thrombosis and the treatment of hypertension,"  Alexander  Bachmann, managing director of Worwag, explains. "These accredited API  audits underline our pioneering role in quality assurance," he adds.

The contracting of accredited, ie, demonstrably-independent, external  GMP auditors is not yet common practice. This situation will, however,  soon change. The currently discussed revision of the European medicinal  product directive 2001/83/EG stipulates that external API audits have to  be exclusively conducted by accredited auditors in the future. So far,  blue inspection body GmbH says it is the only third-party auditor  accredited according to ISO 17020 for GMP of APIs in the European Union.