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Authorities around the world recognise third-party audits by Blue. The impartiality and independence of our third-party audits are monitored by the Germany Accreditation Body DAkkS  (Deutsche Akkreditierungsstelle GmbH).

The accreditation is valid for the scope listed in the D-IS-18678-01-00 certificate.

ISO 9001

For companies located in Germany Blue offers certifications according to ISO 9001 based on the Accreditation according to ISO 17021 (DAkkS Accreditation D-ZM-18678-01-00).

Please contact us in case you require an ISO 9001 certification by internationally recognised pharma experts (e.g. in case your company is a supplier for the pharmaceutical industry).

The certification procedure is outlined here.

High-quality audits

We offer customized third-party audits for all areas of pharmaceutical industry.

In line with our accreditation, our services encompass:

Beyond the scope of our accreditations, we offer additional audit services, such as product-specific compliance audits as well as reviews of system conformity and customized expert opinions, including:

The EXCiPACT Certification Scheme is a credible, high quality, 3rd party international certification scheme for manufacturers, suppliers and distributors of pharmaceutical excipients.
Blue is an EXCiPACT registered certification body. 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 for Excipients. The independent Third-Party-Audits of Blue Inspection Body, which are conducted according to predefined standards, have therefore been especially qualified in addition by EXCiPACT.