The EU MDR Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the cases of a device constituent part being...
This best practice guide to risk management in the biologics industry supply chain is based on the premise that adoption and implementation of the principles and framework reflected in ISO 31000 (Risk Management: 2018) provide an effective and efficient way to support...
The complexity of the support networks needed to deliver biopharma products, makes good supply chain mapping (SCM) essential to ensure reliable drug product supply. This is especially the case given the impact that natural disasters, adverse weather and politics can...
Raw material variability and control of the supply chain are important issues for the biopharmaceutical industry. The industry is still at an early stage in the journey to align the supply base with biopharma’s requirements to improve patient well-being by...
