Custom-tailored 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 such as, for instance, the “for-cause audits“ (i.e. audits for a special reason) as well as for highly specialised audits (e.g. biotech audits), which your product experts do not wish to or cannot conduct on their own.

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).