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 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.
Bourget
Philippe
P
Department of Clinical Pharmacy, Institut Gustave-Roussy, Villejuif, France. bourget@igr.fr
Paci
Angelo
A
Rey
Jean Baptiste
JB
Mercier
Lionel
L
Demirdjian
Sylvie
S
D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D002855:Chromatography, Thin Layer / Q000379:methods / Q000592:standards; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards*; D010607:Pharmacy Service, Hospital / Q000379:methods* / Q000592:standards; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards
D004364:Pharmaceutical Preparations