NEWS

Improving supply chain quality management through a common language

29 June 2022
Supply Chain to Patient
Supply Partner
BioPhorum

Helping manufacturers and suppliers achieve a more consistent, confident, and accurate joint audit approach, the Supply Chain Quality Management Workstream was established in 2020 following a successful pilot. Its latest projects include two new pieces of work:

    1. An optimal process
      This will help users understand the supply chain quality management process at the highest optimal level and will be especially useful for those who are not deeply involved in the process or are new to the requirements for quality management. They will also learn about the impact of this important process on the movement of materials through the supply chain.The optimal process outlines the essential steps. Each process step lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). This exercise drove great discussions between the suppliers and manufacturers and revealed how supply chain quality management is critical to the biomanufacturing inbound supply chain and is relevant to suppliers in all tiers. There is lots of scope here for future conversations, e.g., how do we capture the requirements and quality steps for each relevant tier and supplier?The optimal process will support and recognize that we all generally follow the same steps but may describe them differently. We are offering a standardized view of the process to create clear visibility from the highest to the more detailed levels of the process.

    2. A RACI responsibility assignment matrix
      When creating an optimal supply chain quality management process, it is important to identify where accountability and responsibility lie.So, using the optimal process, we put an explanation against each step, including the typical roles involved. Knowing that each company may use different terminology for each role, we developed a RACI (Responsible, Accounted, Consulted, and Informed) matrix. This is a simplified view of the process and contains some definitions/explanations of the roles. It also recognizes that some individuals in smaller companies may perform multiple roles and therefore wear multiple hats.The RACI matrix will help identify the key part that each role plays in the process and should reduce confusion and create a clear understanding of key decision-makers in each part of the process. There is also a RACI Template that can be used for any process.

These projects show that sharing the optimal high-level steps can simplify a process and invite people into the discussion using a common language. And if each company is performing the same high-level steps, then we will all be working towards some standard ways of working while recognizing the breadth and size of our company members.

These conversations are where there is potential for the greatest benefit of harmonization. After all, we are all only as strong as our weakest link.

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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.

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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.

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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.

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

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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.

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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.

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

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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.

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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.

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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.

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