The biopharmaceutical industry is facing a critical time in the supply of materials. These are often held up by the availability of component parts from supply chains with sub-tiers that are not always visible. There is also a demand to be agile, with the ability to quickly switch sources if there are supply issues.
Second/alternate sourcing is one of the biggest trends in our industry due to learning from the COVID-19 pandemic and ongoing supply chain disruptions. However, industry regulations mean that second sourcing is not always feasible; therefore, it is important to continue to build and strengthen individual company and supply chain business continuity management (BCM) programs.
Supply chains have also become a more global and complex environment, so it is vital that companies understand their supply chains, assess their exposure to risk, and review their ability to respond to supply chain disruptions. One way to do this is by applying sound risk and business continuity management (RBCM) principles and evaluating suppliers on their application of RBCM within their own supply chains.
BioPhorum’s new publication – Business continuity management in the biologic industry supply chain: a best practice guide – can help companies understand the risks and assess their current readiness. It will also strengthen their relationships and communication with suppliers and help the supply chain achieve more resilience.
This best practice document provides high-level guidance on implementing, improving, and monitoring BCM systems in the biologics supply chain. It is based on ISO 22301: Business Continuity Management andcan be used in two ways – as an introduction to BCM and as guidance to benchmark companies’ current processes.
It includes an overview of BCM and guidance on how to do supply chain mapping. This can help increase supply chain transparency, highlight potential risks and enable organizations to implement mitigation measures – ultimately improving supply chain resilience. It also contains a questionnaire to gain insight into the relative maturity of existing BCM practices. Questions include:
- Does your company have a Business Continuity Management (BCM) program that covers the company, site(s), product(s) or manufacturing technologies?
- Does the company have back-up site(s) identified that can be qualified in the case of (major) loss in manufacturing and supply from the primary site or source(s)?
- Has the company conducted a Business Impact Analysis (BIA) to determine the critical business processes/resources and the impact over time if these processes or resources were not available?
The questionnaire is an incredibly useful evaluation tool for assessing the business continuity plans of existing or second/alternate source suppliers, or to help an end-user assess its own plans. Identifying suppliers that have considered RBCM and business continuity planning is critical when evaluating sources of supply that will contribute to the overall supply security of the biopharmaceutical industry.
Using the guide is also an opportunity to evaluate suppliers’ and manufacturers’ existing BCM systems in the biopharmaceutical industry with a straightforward maturity model. It includes suggestions that can improve the maturity level and therefore the effectiveness of the supply chain. It will help all tiers of manufacturers and suppliers gain the full benefits of an effective BCM system to reduce possible production downtimes resulting from the inevitable supply chain disruptions.
BCM is a key feature in improving company and industry responses to an increasingly complex supply chain to benefit patients through a continued supply of safe and effective therapeutic drugs. It is part of an RBCM approach that integrates business functions across the company to improve supply chain resilience.
Supply chain disruptions are inevitable. Therefore, BCM is not just a nice to have but a critical pillar to ensure both short and long-term success.
For more information and to download a copy of the guide, click here.
You can read case studies from representatives in the Risk and Business Continuity Workstream here.