Welcome to GxP / GMP 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 customers’ suppliers work in accordance with Good Manufacturing Practice (GMP) principles.

GxP / GMP 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 9001, 13485 and 15378, 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 autonomy, confidentiality and impartiality of our third-party audits are monitored by Germany’s national accreditation body (Deutsche Akkreditierungsstelle, DakkS). 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 in European Union Blue offers certifications according to ISO 9001 based on the Accreditation according to ISO 17021. ( DAkkS – Deutsche Akkreditierungsstelle: No.: D-ZM-18678-01-00 )

The certification procedure is outlined here –>

Quality management

Pharmaceutical companies face ever-changing market forces and statutory regulations. Hence, they must demonstrate increasingly systematical risk management and consistent GMP compliance. We offer support and guidance in pharmaceutical quality management.

Operating globally

blue inspection body conducts, inter alia, GCP, GLP, GDP, GACP, GEP, GSP, GAMP and GMP audits worldwide. Check out the great variety of our service offerings, high quality standards and custom-tailored service.

Among others, blue audits at/for:

bloomagefreda-logo
alkaloidscorp-logo
chemistry_umicore-logo
cccmhpie-logo
heraeus-logo
evonik_industries-logo
excipact-logo
fjkerui-logo
greenhealth-logo
haosun-logo
hennig-arzneimittel-logo
diapharm-logo
lomapharm-logo
materiamedica-logo
medice-logo
nabriva-logo
ratiopharm-logo
rpglifesciences-logo
rx-360-logo
sunlightchem-logo
tefeng-logo
wdt-logo