Best preparation practices: international convergence and divergence
11 October 2019
S. Crauste-Manciet, University Hospital Bordeaux, FranceV. Salomon, Agence Nationale de Sécurité du Médicament et des produits de santé, France
F. Sadeghipour, CHUV Lausanne, Switzerland
J-F. Bussières, University Hospital Montréal, Canada
A. Beaney, North Tees and Hartlepool NHS Foundation Trust, UK
P. Le Brun, Leiden University Medical Center, The Netherlands
P. Kienle, Cardinal Health Pennsylvanie, USA
The international expert panel will discuss “good manufacturing practices” related to aseptic preparation in hospital pharmacies.
Some selected points extracted from the different regulations will be discussed i.e. Good Preparation Practice (France), Quality Assurance of Aseptic Preparation Services standards (Edition 5) for unlicensed NHS aseptic units, Swiss hospital Good Manufacturing practices, EU Resolution on pharmacy preparation Resolution, CM/ResAP(2011)1, European Resolution on Good Reconstitution Practices (2016), PIC/S guidelines (Europe), USP 797 and 800 (USA), Canadian regulation.
The selected points are the following:
* Microbiological risk levels for aseptic preparation in hospital pharmacies
* Microbiological samplings (air & surfaces): methods, locations, frequencies, results (interpretation and action plan)
* Qualification of operators for aseptic preparation: method, frequencies
* Beyond-to-use date
* Cleanroom design for toxic drug preparation
* Closed systems: definitions