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. It is designed to 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.

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