Welcome to GMP / GxP audit experts

Blue Inspection Body GmbH is Europe’s leading service provider of accredited GMP audits of manufacturers of excipients (excipient audit) and active substances (API audit). Blue’s auditors also verify for finished medicinal products whether our customer’s suppliers work in accordance with Good Manufacturing Practice (GMP) principles.

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GMP / GxP Audits

The abbreviation “GxP“ combines guidelines for “good working practices“ pertaining to various branches of the pharmaceutical industry…

System Audits

Derived from the normative standards and based on the corresponding experience with quality management systems (QM systems) in the area of ISO standards (e.g. 9001), blue offers pure QM system audits…

Special Audits

Certain projects require custom-tailored audits or even expert opinions…

Accreditation

DAkks Logo
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-186878-01-00 certificate.

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, which are conducted according to predefined standards, have therefore been especially qualified in addition by EXCiPACT.

High-quality audits

In line with our accreditation, we offer customized third-party audits for all areas of pharmaceutical industry.

Our services encompass product-specific compliance audits as well as reviews of system conformity and customised expert opinions, such as:

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).  info@blue-inspection.com

The certification procedure is outlined here.

Among others, Blue audits at/for:

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