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

ISO 17020 (Type A) Accreditation

blue inspection body is accredited as a Third Party Auditor according to ISO/IEC 17020 (Type A) for inspection of APIs and excipients for pharmaceutical products and confirmation of accordance with international GMP guidelines. The official accreditation by the German accreditation body DAkkS proves the independence, confidentiality and impartiality of our Third- Party-Audits. DAkkS is also monitoring the content quality of our audit reports, the depth of our inspections and our decisions concerning any certification.

As the only service provider in the European Union, blue inspection body is accredited with the highest accreditation level Type A of ISO/IEC 17020. Only the Swiss health authority, Swissmedic, has been accredited on a Type A level. In routinely performed re-certifications the qualification of our auditors, the conformity of our quality management systems with international guidelines, the content quality of our audits and the impartiality of our services is constantly monitored by DAkkS. 

Our accreditation on the highest possible level simplifies the mandatory qualification of Third-Party-Auditors that all Marketing Authorisation Holders have to perfom. The full membership of DAkkS in the „European co-operation for Accreditation (EA)“ and the „International Accreditation Forum (IAF)“ guarantees, that API reports by an DIN EN ISO 17020/17021 accredited inspection body are accepted by authorities worldwide.

Policy on impartiality

blue inspection body GmbH performs audits and certification processes on behalf of its clients and bases all its business activities on the following business model and quality policy:

The management of blue inspection body GmbH considers itself responsible for quality and customer satisfaction with regard to all customers to which it offers its services. Impartiality is the top priority in the performance of audits and certification processes. Conflicts of interest are identified and assessed to ensure that the activities remain objective. blue inspection body GmbH does not offer any consulting services, guaranteeing strict neutrality and independence. blue inspection body GmbH’s decisions are based on objective evidence; they are not influenced by any commercial, financial or other interests. blue inspection body GmbH also considers the expectations of employees in its activities.

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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