blue – ISO 17020 (type A) accredited inspection body for API GMP audits

EXCiPACT audits

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 transparent and 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.

blue inspection body GmbH is one of the very first companies to be registered as a certification body according to EXCiPACT guidelines. The EXCiPACT certification programm sets the highest quality standards in the industry and is recognised worldwide. Our auditors' qualification complies to and exceeds the requirements of ISO 17021-1:2015. Furthermore, all auditors have successfully completed an EXCiPACT qualification training course and exam.

Benefits of EXCiPACT certified audits:

  • Internationally acknowledged proof for GMP/GDP systems which meet highest standards
  • Recognised worldwide by all relevant parties and authorities
  • Significantly reduced audit effort by contracting Third Party Auditors
  • Cost savings without compromising quality
  • Improved transparency within the supply chain of pharmaceutical excipients
     

Audits with EXCiPACT certification

blue inspection GmbH performs audits according to the current EXCiPACT standards: The basic requirement to achieve an EXCiPACT conform certification is a quality management system according to ISO 9001. Based thereupon we perform a professional and independent audit of the GMP or GDP procedures, beginning with a GAP analysis of the delta between ISO 9001 and EXCiPACT. The subsequent system analysis determines and assesses the management system in question with all corresponding processes, regulations and documents in form of a system audit.
If all requirements are met, we issue a certificate with EXCiPACT seal which will be valid for three years. In the following two years we will perform surveillance audits. After three years a re-certification is due.
 

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 62562040

contactNOSPAM@blue-inspection.com
chinaNOSPAM@blue-inspection.com
indiaNOSPAM@blue-inspection.com

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