GERPAC Consensus Conference – Guidance on the Assignment of Microbiological Shelf-life for Hospital Pharmacy Aseptic Preparations

• Main Authors: Crauste-Manciet Sylvie, Krämer Irene, Lagarce Frederic, Sautou Valerie, Beaney Alison, Smith Julian, Fenton-May V’Iain, Hecq Jean-Daniel, Sadeghipour Farshid, Brun Paul Le
• Format: Article
• Language: English
• Published: De Gruyter 2020-05-01
• Series: Pharmaceutical Technology in Hospital Pharmacy
• Subjects: shelf-life; microbiological; consensus; guidance
• Online Access: https://doi.org/10.1515/pthp-2020-0001

All dosage forms prepared in hospital pharmacies should be labelled with an appropriate shelf-life. This shelf-life should be validated taking chemical, physical and microbiological data into consideration. This guidance focuses on parenteral aseptically prepared products, as they are high-risk 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 preparations prepared from the same initial bulk admixture.