French Good Compounding Practices (BPP): Environnemental monitoring of cleanrooms in hospital pharmacies
6 October 2023T Storme (Paris - France)
The new version of the BPP is intended to be more practical, and is designed to help compounding pharmaceutical teams at the hospital and community pharmacies.
Field inspectors reported to de drafting comitee that the monitoring of cleanrooms and equipement varies greathly from site to site. A need for formalization
In order to facilitate inspections and, above all, to provide a minimum level of monitoring adapted to the risks associated with the products handled, practical tools and recommendations have been integrated into the BPP 2022 version.
To allow practices evolution over the time, BPP are based on normative texts. Moreover, to enable thoughtful adaptation to local conditions, variations on the "dogmas" are possible, using risk analysis to focus on the identified risk (product, environment, personnel).
The aim of this presentation is to highlight the BPP evolutions and to discuss their monitoring proposals.