Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy

Isabelle Borget, Isabelle Laville, Angelo Paci, Stefan Michiels, Lionel Mercier, Romain Pacôme Desmaris, Philippe Bourget

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    23 Citations (Scopus)

    Résumé

    Background: About 26,000 chemotherapeutic batches were produced in 2003 in the Institute Gustave Roussy and 83% were qualitatively and quantitatively assessed in post-production controls via an analytical platform. The rate of non-conformity (outside the specification limits of the target concentration ±10%) decreased from 8.9% to 2.2% between years 2001 and 2003. A cost- and time-saving acceptance sampling plan was applied to assay fewer batches whilst maintaining an accurate estimate of the quality level. Methods: The opportunity to apply a single sampling plan by attributes with an acceptance quality level of 2.2% was evaluated. A prognostic study using a logistic regression model was performed for some drugs to identify risk factors associated with the non-conformity rate of preparations. Results: Out of 26 drugs, 17 have not been sampled, since they were prepared less than 400 times per year. For six drugs, a reduction of about 50% in the number of assays was estimated. Three drugs were "at risk" of being non-conform: for these drugs, all batches were analysed. Conclusions: The sampling plan allowed a reduction of almost 8000 analyses with respect to the number of batches analysed for 6 drugs. For the 3 drugs with the higher risk to be non-conform, associated risk factors were identified to set up corrective actions.

    langue originaleAnglais
    Pages (de - à)92-98
    Nombre de pages7
    journalEuropean Journal of Pharmaceutics and Biopharmaceutics
    Volume64
    Numéro de publication1
    Les DOIs
    étatPublié - 1 août 2006

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