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), active substances (API audit) and finished medicinal products. On behalf of our customers worldwide, blue's auditors verify whether suppliers work in accordance with the principles of Good Manufacturing Practice (GMP).
Autonomy, confidentiality and impartiality of our third-party audits are monitored by the German Accreditation Body (Deutsche Akkreditierungsstelle, DakkS). As a result, third-party audits provided by blue are recognised by authorities throughout the world.
Located in Stuttgart (Germany), mdc medical device certification GmbH is our co-operation partner in the EXCiPACT certification scheme for pharmaceutical excipients. 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 mdc and 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
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.
GMP Search App (Android)
Get all relevant GxP documents around the globe on your smartphone - free of charge with our GMP Search app:
Achieving More Effective and Efficient GMP Auditing
Risk-Based Auditing of Active Pharmaceutical Ingredient Manufacturers - Recommendations for Standards and Minimal Requirements
GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report
API Manufacturing: Complying with International GMP Regulations