Guidance on the Assignment of Microbiological Shelf-life for Hospital Pharmacy Aseptic Preparations - 2020
All dosage forms prepared in hospital pharmacies should be labelled with an appropriate shelf-life. This shelflife should be validated taking chemical, physical and microbiological data into consideration. This guidance focuses on parenteral aseptically prepared products, as they are highrisk preparations. The risk is exacerbated by a requirement for longer shelf lives for reasons of economy and efficiency.
The scope of this guidance includes individual patient preparations, preparations prepared in series (same type of preparation being repeatedly prepared) and batch préparations prepared from the same initial bulk admixture.