Centrally prepared cytotoxic drugs : what is the purpose of their quality control ?

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TitreCentrally prepared cytotoxic drugs : what is the purpose of their quality control ?
Type de publicationArticle de revue
AuteurLagarce, Frédéric
1, 2
PaysAllemagne
EditeurDe Gruyter
VilleBerlin
TypeArticle scientifique dans une revue à comité de lecture
Année2017
LangueAnglais
DateMars 2017
Numéro1
Pagination29-33
Volume2
Titre de la revuePharmaceutical Technology in Hospital Pharmacy
ISSN2365-242X
Mots-cléschimiothérapies, contrôle, Hôpital, pharmacie, qualité
Résumé en anglais

To assess the quality of centrally prepared cytotoxics a global approach is being implemented by pharmacists. A risk analysis is performed, and then many in-process controls are proposed. The aseptic process and the material are also fully validated. Moreover the skills of pharmacy technicians are being checked and monitored over time. This short opinion paper discusses the place of in-process quality control within the quality system applied to cytotoxic preparations. It also discusses the pros and cons of analytical control of the final product versus continuous control of each preparation step by eye witness or an electronic device such as a camcorder. Finally the relevancy of controls is discussed in function of different cases and of the human and material resources available in the pharmaceutical technology cytotoxic unit.

URL de la noticehttp://okina.univ-angers.fr/publications/ua16148
DOI10.1515/pthp-2017-0006
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https://www.degruyter.com/view/j/pthp.2017.2.issue-1/pthp-2017-0006/pthp...