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

• Main Authors: Crauste-Manciet Sylvie (Author), Krämer Irene (Author), Lagarce Frederic (Author), Sautou Valerie (Author), Beaney Alison (Author), Smith Julian (Author), Fenton-May V'Iain (Author), Hecq Jean-Daniel (Author), Sadeghipour Farshid (Author), Brun Paul Le (Author)
• Format: Book
• Published: De Gruyter, 2020-05-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 prep...