Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy.
Eur J Pharm Biopharm
; 64(1): 92-8, 2006 Aug.
Article
en En
| MEDLINE
| ID: mdl-16750352
ABSTRACT
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.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Servicio de Farmacia en Hospital
/
Preparaciones Farmacéuticas
/
Cromatografía Líquida de Alta Presión
/
Composición de Medicamentos
/
Neoplasias
/
Antineoplásicos
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Eur J Pharm Biopharm
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
Año:
2006
Tipo del documento:
Article
País de afiliación:
Francia