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

• Published in: European journal of pharmaceutics and biopharmaceutics Vol. 56; no. 3; pp. 445 - 451
• Main Authors: Bourget, Philippe, Paci, Angelo, Rey, Jean-Baptiste, Mercier, Lionel, Demirdjian, Sylvie
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.11.2003; Elsevier Science
• Subjects: Analysis; Biological and medical sciences; Chemotherapy; Chromatography, High Pressure Liquid - methods; Chromatography, High Pressure Liquid - standards; Chromatography, Thin Layer - methods; Chromatography, Thin Layer - standards; Clinical pharmacy; General pharmacology; High performance thin layer chromatography; Medical sciences; Pharmaceutical Preparations - analysis; Pharmaceutical Preparations - standards; Pharmacology. Drug treatments; Pharmacy Service, Hospital - methods; Pharmacy Service, Hospital - standards; Quality assurance; Quality Assurance, Health Care - methods; Quality Assurance, Health Care - standards; Quality control; High performance thin layer chromatography; Chemotherapy; Quality assurance; Quality control; Clinical pharmacy; Drug; High performance; Methodology; Hospital pharmacy; Thin layer chromatography; Preparation; Clinical pharmacology; Control method; Quality management
• ISSN: 0939-6411; 1873-3441
• DOI: 10.1016/S0939-6411(03)00117-6

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.