blue inspection body GmbH

blue inspection body GmbH is the leading provider of GMP audits of active substances and excipients in the EU. On behalf of manufacturers of medicinal products and marketing authorisation holders, our auditors globally monitor compliance with good working practices, which are stipulated in various GxP standards (Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Good Distribution Practice, etc.).

Certified third-party auditor

As a third-party auditor, blue is certified 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”. Autonomy, confidentiality and impartiality of our third-party auditors is monitored by the German Accreditation Body (Deutsche Akkreditierungsstelle, DakkS).

Development

blue inspection body GmbH was founded in 2007. On behalf of pharmaceutical companies, blue auditors annually conduct more than 100 audits worldwide! Our team of auditors receives support from a professional advisory board consisting of high-profile current and former representatives from the industry and the authorities. We are continuously searching for qualified personnel since blue has been steadily growing over the years.

Among others, blue audits at/for:

chemistry_umicore-logo
heraeus-logo
evonik_industries-logo
excipact-logo
hennig-arzneimittel-logo
diapharm-logo
lomapharm-logo
medice-logo
nabriva-logo
ratiopharm-logo
rpglifesciences-logo
wdt-logo