Contribution of high-performance thin-layer chromatography to a pharmaceutical quality assurance programme in a hospital chemotherapy manufacturing unit.
Eur J Pharm Biopharm
; 56(3): 445-51, 2003 Nov.
Article
en En
| MEDLINE
| ID: mdl-14602189
ABSTRACT
The Department of Clinical Pharmacy (DCP) in the Institut Gustave-Roussy (IGR) is equipped with a high-performance thin-layer chromatography (HPTLC) analytical platform. One of the numerous possible uses of HPTLC is post-production quality control of chemotherapy manufacturing. After 3 years of existence, routine validation of manufactured batches has attained considerable maturity 24 cytotoxic agents can be controlled in terms of identity, purity and concentration. Approximately 50% of the sampled preparations are assessed. More than 97% were within specifications, 1.6% were not, probably due to incorrect homogenization before sampling; and 1% were not evaluable. Using HPTLC in a hospital manufacturing unit contributes to quality assurance programmes such as accreditation to which the IGR DCP is now committed but also ISO 90012000 certification concerning the chemotherapy manufacturing unit.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Servicio de Farmacia en Hospital
/
Garantía de la Calidad de Atención de Salud
/
Preparaciones Farmacéuticas
Idioma:
En
Revista:
Eur J Pharm Biopharm
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
Año:
2003
Tipo del documento:
Article
País de afiliación:
Francia