Optimization of the qualitative parameters used for batch release of injectable anticancer drugs
2 ARNA Laboratory-ChemBioPharm U1212 INSERM - UMR5320, CNRS - University of Bordeaux, France
The merging of our 3 cytotoxic production units leaded us to work on harmonization of the processes in the perspective to help the future organization of an unique site of production. The batch release of chemotherapies and in particular the qualitative parameters’ assessment was found to be one of the most heterogeneous between our three production sites. Harmonizing the qualitative criteria of validation is a security issue in a context of production activities’ management.
The 3 sites preparation’s qualitative controls were listed using internal quality documents, control’s materials and pharmacists’ interviews. An impact assessment study was carried out, by defining the level of risk of the lack of verification of each control.
Results & Discussion
All sites combined, 31 criteria are verified: volume, name, products’ batch number, patient identity, preparation’s quality and devices used. 30% of the criteria are common between the 3 preparation units and 25% are specific. Various qualified personal (pharmacy student, pharmacy resident, pharmacy technician, pharmacist) are involved in the qualitative assessment. Qualitative parameters are registered both during preparation and on the final product according to 3 methods of traceability (manufacturing sheet, label, Excel® spreadsheet). The impact study revealed consequences for the patient (error or lack of administration), for the staff (risk of exposure), for the organization and for the preparation’s quality. Depending on the risk, 5 qualitative criteria were kept: organoleptic verification (color, precipitate, bubble, leak), presence of the appropriate device, label, perfusion-line filter for administration and closure of the packaging. The qualitative parameters we decided to remove from the list were considered to have no added value. As an example, the registration of diluent’s batch number was removed because the computerized system does not allow the connection of this information with the final preparation.
This work leads to the rationalization of qualitative controls and to the validation of their relevance. The continuation of the work will be focused on the design of the single-compilation tool providing a non-conformity’s cross-sectional analysis.