Normes logistiques de la chaîne du froid pharmaceutique & Guide de conformité 2025
Keeping medicines safe isn’t only about making them — it’s about delivering them without breaking their temperature range. Pharma cold chain logistics standards ensure vaccines, biologics and cell therapies remain potent from lab to patient. Dans 2025, these rules are stricter and more interconnected than ever. À peu près 43 % of newly approved drugs require cold storage and up to 50 % of vaccines are wasted globally due to poor temperature control. This guide answers your key questions about regulations, temperature requirements and technologies so you can protect patients, avoid penalties and stay competitive. Why pharma cold chain logistics standards matter and how they protect product integrity Key regulatory frameworks (PIB, DSCSA, VOICI LE TCR, OMS, USP <1079.2>) that govern global cold chain compliance Temperature categories and storage definitions for vaccines, biologics and gene therapies DSCSA deadlines and what electronic traceability means for wholesalers and dispensers Best practices for packaging, surveillance, recordkeeping and staff training Emerging technologies — IoT sensors, Analyse de l'IA, blockchain, drones, sustainable packaging and...