As we all adjust to the progressive impact of Covid-19, one consequence has been an increased focus on the biologics supply chain. In such a dynamic and challenging environment, many BioPhorum members are actively engaged in seeking to maintain surety of supply in therapeutic drugs.
In BioPhorum, Supply Partner members of the Risk and Business Continuity Management Workstream (RBCM) have been working hard to review and agree what constitutes best practice in this crucial area for our industry.
At a recent meeting, members – both drug manufacturers and suppliers – met to review and refine a draft Best Practice Guide to Risk Management in the Biologics Supply Chain.
RBCM05: February 2020 – Representatives from the RBCM Workstream
The team confirmed that the current International Standard on Risk Management (ISO 31000 of 2018) represents a straightforward, and effective, model that can be applied to any industry and was one that they aligned on as representing best practice in this critical business function. The intent is to encourage more widespread adoption and implementation of the principles and outline processes in ISO 31000 (2018): both in biologic drug manufacturing and throughout the supporting supply base.
The team recognised that for companies with existing and relatively mature Enterprise Risk Management Systems it would not be necessary to fundamentally revise their current approach. Instead, a best practice guide maturity model could be applied to help review current practice and undertake a gap analysis to seek further improvement.
At the meeting, members agreed that not all companies could follow this approach as risk management systems are not always at the required level of maturity. For such companies, the Best practice guide to risk management in the biologics supply chain planned for publication in Q2 2020 should provide a model to help strengthen risk management practices. Also, members aim to flow a more consistent approach to Risk Management throughout the supply chain from Tier 1 suppliers into the various sub tiers. This activity will enhance overall surety of supply and minimize the impact of disruptions to the supply chain.
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