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Contribution of high-performance thin-layer chromatography to a pharmaceutical quality assurance programme in a hospital chemotherapy manufacturing unit

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 exis...

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Bibliographic Details
Published in:European journal of pharmaceutics and biopharmaceutics 2003-11, Vol.56 (3), p.445-451
Main Authors: Bourget, Philippe, Paci, Angelo, Rey, Jean-Baptiste, Mercier, Lionel, Demirdjian, Sylvie
Format: Article
Language:English
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Summary: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 9001:2000 certification concerning the chemotherapy manufacturing unit.
ISSN:0939-6411
1873-3441
DOI:10.1016/S0939-6411(03)00117-6