Press Releases from blue inspection body GmbH (8 total)
blue inspection body reports on experiences with excipient audits
The industry initiative EXCiPACT was launched a year ago to improve monitoring of pharmaceutical excipients. At the CPhI China in Shanghai and the ExcipientFest Europe in Amsterdam, the auditors of blue inspection body (www.blue-inspection.com) have now drawn an initial conclusion: “Overall, the level of awareness for Good Manufacturing and Good Distribution Practices at excipient manufacturers has increased significantly in the past twelve months,” declared lead auditor Dr. Norbert Waldöfner in…
Aiming for tighter surveillance of excipients used in medicines
Baltimore (USA), Münster (DE), 06 May 2013. The EXCiPACT certification scheme, an initiative of industrial associations from excipient and pharma suppliers, has officially been launched in the US. EXCiPACT is aiming for an independent and impartial monitoring of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance. The manufacturing and distribution operations of excipient suppliers will be subject to regular on-site monitoring by auditors from accredited Certification Bodies. A…
Manufacturers of Pharma-Excipients aiming for certified monitoring
Muenster, 29 November 2012. Supported by extensive professional knowledge of blue inspection body GmbH, the mdc medical device certification GmbH represents the first European Certification Body for pharmaceutical excipients. mdc and EXCiPACT have signed a respective framework agreement. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharma suppliers, aiming for a professional surveillance of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance. The…
Blue Inspection Body audits Good Manufacturing Practice compliance of Biotec-der …
Muenster (Germany), 16 March 2012. The first accredited Good Manufacturing Practice (GMP) inspection body in Europe broadens its range of services: blue inspection body (www.blue-inspection.com) successfully completed an audit of an antibody manufacturing site for a Russian pharmaceutical company. The contract giver, OOO NPF MATERIA MEDICA HOLDING, uses the Biotech-derived glycoprotein for manufacturing homoeopathic medicinal products supplied to the Russian market.
Pharmaceutical manufacturers must verify compliance with GMP standards along the…
blue inspection body extends the API audit team by Dr Norbert Waldöfner
Muenster (Germany), 22 June 2011. Effective June 1st, Dr Norbert Waldöfner was nominated as a new GMP-Auditor of blue inspection body GmbH (blue-inspection.com). Thus the first accredited European inspection body for active pharmaceutical ingredients (APIs) extends the team of available team to twelve qualified auditors. At the same time the Chemist will takeover the function as quality management representative. On behalf of pharmaceutical companies, blue inspection body GmbH examines the…
blue inspection body GmbH strengthens the team for global API audits with Bohong …
Münster (Germany), 12 Mai 2011. Starting beginning of May Bohong Meng joined the team of auditors at blue inspection body GmbH (blue-inspection.com) in Münster, Germany. She will be assessing the Good Manufacturing Practices of active pharmaceutical ingredient (API) suppliers for the third-party audit service provider on behalf of pharmaceutical companies. The main focus of her activities will be the monitoring of Asian manufacturers. „This region of the world shows the…
blue inspection body celebrates 50 GMP audits
Münster (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,…
blue inspection body audits active pharmaceutical ingredient manufacturers in Ch …
Muenster (Germany), 13 February 2009. The audit service provider blue inspection body GmbH (blue-inspection.com) will be conducting third-party audits of excipient and active pharmaceutical ingredient (API) 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…
