Business continuity management in the biologic industry supply chain: a best practice guide
Supply chains have become increasingly global, complex and opaque, with companies outsourcing production to contract manufacturers, using new modalities (such as cell and gene therapies) and exploring novel ways to reach patients.
Multiple suppliers, regional sourcing, difficulties in the timely supply of critical raw materials, etc., mean it is vital that all companies understand their supply chain, assess their relative exposure to risk, and review their ability to respond to the inevitable supply chain disruptions.
An effective business continuity management system (BCMS), integrated with related risk management systems, is part of an approach that can help identify risk and effective mitigation strategies. This will reduce a company’s risk exposure and lead to an improved ability to respond and recover operations adversely impacted by disruption to the supply chain.
This paper provides best practice guidance for effective BCMS in the biologics supply chain. It can be used in two ways. First, as an introduction to BCMS and second, as guidance to benchmark companies’ current processes. It is based upon the framework in ISO 22301.
While the principles and framework can be applied to any industry, the guide has been tailored to address the biologics supply chain. It forms part of a suite of documents published by BioPhorum to strengthen the surety of supply to benefit companies, industry, and patients. It is not intended to provide an industry standard but is best practice guidance that any company in the industry can use to improve supply chain resilience.
|Business continuity management in the biologic industry supply chain- a best practice guide March 2023.pdf|
|Business continuity management questionnaire March 2023.xlsx|
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- Create Date 29th March 2023
- DOI https://doi.org/10.46220/2023SP001
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