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.
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.
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.
line with our accreditation, we offer customized third-party audits for
all areas of pharmaceutical industry.
Among others, we are an approved auditing firm for the international supply chain consortium Rx-360.
Our services encompass product-specific compliance audits as well as reviews of system conformity and customised expert opinions, such as:
- API GMP audits
- Starting materials/Excipient GMP audits
- Finished medicinal product GMP audits
- QM system audits
- GAP analysis
- Mock audits
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.
Quality managementPharmaceutical 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.
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