Biopharmaceutical packaging and shipping practices also have adapted to accommodate the risk-based quality-management guidelines that have taken hold of the industry. Confidence in the safety and integrity of product during shipment is improved by real-time monitoring of materials in route, improved analytics for detecting raw-material contamination, better understanding of preventing leachates from closers/stoppers, and long-term supplier–end-user partnerships to ensure continuity and quality of raw materials throughout a product’s lifecycle. This chapter looks at the evolution of current approaches to logistics and cold-chain management drawing from survey responses and from a selection of BPI authors.

Get the eBook Now