PharmDev Innovations

Auditing

As experience has shown an audit is not complete if it only follows a checklist where all items are systematically checked and ticked during a walk through the premises.

Quality of audit findings is heavily impacted also by intuition. Consequences based on both systematic and intuitive findings and approaches are normally leading to faster compliance and less deviations (and respective reportings).

Such an audit intuition is a matter of experience. Similar to a customs officer, developing an instinct over years on whom to stop and control, an auditor should also listen to his gut feelings beyond any checklist approaches.

Auditing manufacture of investigational medicinal products in particular requires interdisciplinary experience in this complex environment to get to reasonable audit results.

If ideally the auditor is acting as a Qualified Person himself, he will always question, if he would administer drugs from the audited facility to humans and release with a clean conscience.

Our auditors are following such an approach.

We were happy to support you in organising a well structured audit system (including respective SOPs) with necessary documents (like audit order, audit report, audit results and CAPA plan).

What can happen beyond "normal" audit results is illustrated by the Glochem case in India from 2010.

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