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

Custom audits and expert opinions

Certain projects require custom-tailored audits or even expert opinions. These requirements may not be relevantly or adequately covered by the standard service offerings of blue inspection body.

Custom-tailored audits

A process audit conducted by external auditors in a particular department reveals previously unidentified gaps and GMP compliance risks (gap analysis audit).

In addition, our qualified auditors provide specific support for particularly important audits, for instance:

  • For-cause-audits
  • FDA-readiness audits
  • GAP analysis audits
  • GMP audits focussing on specific areas
  • Highly sophisticated process/product audits
  • Outstanding or challenging tasks.

We have the experience and the people to deliver. You will be satisfied and our expertise and high-quality audit reports will exceed your expectation.

Expert opinions

In corporate mergers and acquisitions, blue inspection body carries out audits of GMP compliance status of the quality system or the status of product realisation process (Technical Due Diligence, Expert Opinion).


blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 9759950-100

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