Creation of an auditing tool for an aseptic preparation unit according to the french good preparation practices (GPP) - Assessment of a chemotherapy preparation unit

Lucie Baillet1, Latifa Haddad1, Michèle Vasseur1, Christophe Berneron1, Amandine Menet2, Christophe Lestrez3, Bertrand Decaudini1, Pascal Odou1 1 Institut de pharmacie, CHRU Lille, France
2 Ingénieur qualité, CHRU Lille, France
3 Ingénieur responsable de la qualité de l’air, CHRU Lille, France

In the objective to improve our chemotherapy preparation process, we entered into a quality approach starting with the creation of a thematic auditing tool.

Taking the French GPP as a reference, restricted to the aseptic injectable preparations, a group of experts elaborated an auditing grid. Each item in this grid refers to one single object. We removed from the grid general points, definitions and repetitions. Items not relevant to our activity were classified as Not Applicable (NA). The thematic classification of these items, defined according to an approach of our preparation process, results in a fast and practical auditing tool. We selected 3 ways of auditing: observing, documentary checking and questioning. The audit was carried out by 3 auditors with knowledge in quality or pharmaceutical technology.

The tool comprises 809 items including 363 NA to our unit, 117 repetitions were deleted. The audit took 17 hours and involved 5 people.
The rates of conformity to French GPP are:

This exhaustive assessment will result in an action plan, prioritized according to an analysis of the criticity of the non-conformities. This tool highlights recommendations required by the French GPP on a given field. Moreover, the auditing tool will be soon tested in a radiopharmacy preparation unit in order to validate its applicability and its relevance.

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