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

Welcome to the audit experts

blue inspection body GmbH is Europe’s leading service provider of accredited GMP audits of API manufacturers (API audits) and excipient manufacturers (excipient audits). blue’s auditors also verify whether the suppliers of our clients from the pharmaceutical industry work in accordance with Good Distribution, Engineering or Automation Practices and similar GxP principles. 

Accreditations

Our competence, independence and neutrality is confirmed by the Deutsche Akkreditierungsstelle public authority.

GMP audits

As third-party auditors we inspect the GMP compliance of excipient and API manufaturers – and much more.

EXCiPACT audits

blue inspection body is an EXCiPACT registered certification body for excipients and active ingredients.

About us

For over a decade blue inspection body GmbH has been the leading provider of third party audits.

Your blue audit benefits:

  • Independent inspection of supplier quality for optimum authority acceptance
  • Assignment of specialist auditors with experience in the relevant processes/technologies
  • Reduction of work-load for in-house QP´s
  • Reduction of audit expenses (absence of in-house QP, travel or translation costs, etc.)
  • Organizational improvements (planning, VISA, vaccination, language, cultural barriers, etc.)
  • Unbiased assessment against established standard

Discover blue

Audits are an integral part of supplier qualification irrespective of the services or products sourced. Based upon accepted standards and current legal requirements, blue inspection body conducts independent and competent audits – worldwide. This service is offered without limitation to every participant of the supply chain e.g.

  • Pharmaceutical companies
  • (Contract) Manufacturers
  • Distributors
  • Manufacturing Authorisation Holders
  • Suppliers
  • Traders
  • Consultants or other interested parties

Manufacturing Authorisation Holders (MAH) are responsible for compliance with the Good Manufacturing Practices (GMP) throughout their process chain. These audits can be conducted by qualified persons or outsourced to qualified third parties.

    High-quality audits

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

    In line with our accreditation, we offer customised 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:

    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.

    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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