TY - JOUR
T1 - Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy
AU - Borget, Isabelle
AU - Laville, Isabelle
AU - Paci, Angelo
AU - Michiels, Stefan
AU - Mercier, Lionel
AU - Desmaris, Romain Pacôme
AU - Bourget, Philippe
PY - 2006/8/1
Y1 - 2006/8/1
N2 - 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.
AB - 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.
KW - Cancer
KW - Chemotherapy
KW - High performance thin-layer chromatography (HPTLC)
KW - Post-production controls
KW - Quality assurance
KW - Sampling plan
UR - http://www.scopus.com/inward/record.url?scp=33746519164&partnerID=8YFLogxK
U2 - 10.1016/j.ejpb.2006.04.002
DO - 10.1016/j.ejpb.2006.04.002
M3 - Article
C2 - 16750352
AN - SCOPUS:33746519164
SN - 0939-6411
VL - 64
SP - 92
EP - 98
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
IS - 1
ER -