blue inspection to offer exipient and API audits in Asia
The audit service provider blue inspection body GmbH (www.blue-inspection.com) will be conducting third-party audits of excipient and active pharmaceutical ingredient manufacturers in Asia at the beginning of March. The company, accredited for this purpose, offers manufacturing authorisation holders in Europe to take part in this audit travel in order to qualify their suppliers from the regions of Hyderabad (India) and Shandong (China).
API audits are regarded as important means to enhance drug safety. The audits have to be conducted at the premises of ingredient producers either by the pharmaceutical manufacturer itself, or by a specifically qualified third-party auditor. They are a prerequisite for importing APIs into the European Union and processing them into medicinal products.
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