NEWS

How to make business continuity management a critical pillar of your supply chain success

1 April 2023
Supply Partner
Ciera Clayton
Global Change Facilitator

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.

NEWS
A major milestone – a harmonized approach to product carbon footprint data
NEWS
Combination products – MediPhorum’s ‘state of the nation’ report
NEWS
Inaugural BioPhorum Quality face to face – get involved
NEWS
Forecasting the demand for single-use systems
NEWS
The new Drug Substance Strategic Value Framework – addressing industry pain points

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing