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 biologics industry growth while maintaining, and potentially increasing, benefit to patients and companies, in addition to satisfying the demands of regulatory agencies and meeting legislative requirements. The guide does not seek to mandate adoption of the ISO 31000 standard but does encourage the industry to review their approach to risk management to validate, or refine and improve, current company practice, in terms of principles and risk management processes in this vitally important business function.
Importantly, the guide seeks to encourage all within the biologics industry to move toward a more consistent approach to risk management and to flow this initiative throughout the industry and the supply chain. It is not intended solely for biologic manufacturers or for the major tier 1 suppliers but as a strategic objective for all companies that are engaged within the industry to move toward a more consistent, structured approach to risk management; those that directly support manufacturing as well as those who source the raw materials and are involved in warehousing and distribution. The biologics supply chain is global and complex. Disruptions quickly impact not only individual companies but the wider industry. Crucially, it is the patient that the industry serves and this guide makes the case that a more consistent, and structured approach to risk management will benefit patients, companies and the industry as a whole.