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

被引：15

作者：

Bourget, P ^{[1
]}

Paci, A ^{[1
]}

Rey, JB ^{[1
]}

Mercier, L ^{[1
]}

Demirdjian, S ^{[1
]}

机构：

[1] Inst Gustave Roussy, Dept Clin Pharm, F-94805 Villejuif, France

来源：

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS | 2003年 / 56卷 / 03期

关键词：

high performance thin layer chromatography; chemotherapy; quality assurance; quality control; clinical pharmacy;

D O I：

10.1016/S0939-6411(03)00117-6

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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. (C) 2003 Elsevier B.V. All rights reserved.

引用

页码：445 / 451

页数：7

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