blue – ISO 17020 (type A) accredited inspection body for API GMP audits

blue inspection body GmbH

blue inspection body, established in 2007, is an independent inspection organisation that is highly experienced in conducting GxP-audits globally. To ensure and demonstrate our dedication for excellence we have been accredited according to ISO/IEC 17020 and ISO/IEC 17021. blue inspection body is the first and only contract auditor in the European Union that has ever been accredited with the highest level of impartiality, Type A. Along with blue only the Swiss health authority, Swissmedic, has been accredited on a Type A level.

Accreditations

Our competence, independence and neutrality is confirmed by the Deutsche Akkreditierungsstelle public authority.

About us

Over the past decade blue has proven its outstanding experience in more than 1,000 audits. Our auditors are all highly qualified pharmaceutical professionals. The majority of them looks back on more then 15 years business and audit experience and has a PhD in a relevant field. Our auditors are regularly invited to take part in panel discussions and to share their professional competence.

Our audit reports fulfill regulatory requirements and demonstrate the GMP compliance of the audited suppliers. Global supply chains are increasingly complex and involve many different parties such as raw material suppliers, manufacturers, logistics providers and national regulatory bodies.

Besides being contracted directly for on-site audits from life science companies, blue is also recognized as a competent service provider for shared audits. Furthermore, blue is an accredited EXCiPACT certification body. Thanks to our longstanding international experience we are intensely familiar with the individual requirements and particularities of authorities worldwide.

Accredited third-party auditor

As a third-party auditor, blue is accredited to ISO standard ISO/IEC 17020 for “inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules”. In addition, we are accredited to ISO/IEC 17021 for the certification of quality management systems according to DIN ISO 9001:2015. The independence, confidentiality and impartiality of our third-party auditors is monitored by the German Accreditation Body (Deutsche Akkreditierungsstelle, DAkkS).

The excellent quality standard that accreditation confirms, includes among other measures  a mandatory training schedule for all our auditors including retrainigs every year.

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 62562040

contactNOSPAM@blue-inspection.com
chinaNOSPAM@blue-inspection.com
indiaNOSPAM@blue-inspection.com

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