Change Notification

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Change Notification: A guide to change notification packages for single-use manufacturing systems

Change Notification: A guide to change notification packages for single-use manufacturing systems

Sep 2020 | , , ,

This paper is intended to be an all-inclusive manual (a one-stop shop) on change notification best practices for single-use biomanufacturing systems. A summary of previous publications is also provided. This includes improvement updates to the decision tree and supporting table based on user feedback. This paper delineates the main attributes of an effective supplier change notification program. The team’s vision for this toolkit is to facilitate adoption of these practices by the majority of end-users and suppliers in the single-use supply chain. In time, it is hoped that these practices will become reflected in quality management practices and in formal business agreements.

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Change notification: Stakeholder analysis – supply partner

Change notification: Stakeholder analysis – supply partner

Jul 2019 | ,

This tool allows users to document key stakeholders who are impacted by the adoption and implementation of the Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems with the purpose of identifying the cross-functional team members required to assist in the implementation and execution of the proposal, as well as the challenges and advantages associated with adoption and implementation.

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Change notification: Stakeholder analysis – supply partner

Change notification: Stakeholder analysis – biomanufacturer

Jul 2019 | ,

This tool allows users to document key stakeholders who are impacted by the adoption and implementation of the Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems with the purpose of identifying the cross-functional team members required to assist in the implementation and execution of the proposal, as well as the challenges and advantages associated with adoption and implementation.

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Single-use, change notification: BioPhorum change notification levels and decision tree – biomanufacturer letter template

Single-use, change notification: BioPhorum change notification levels and decision tree – biomanufacturer letter template

Jul 2019 |

One of the key aspects identified as part of the proposal for change notification best practices is good, clear and timely communication. Each company must take responsibility for communication around individual changes following its own practices and policies. The templates provided below are provided for use in communicating engagement with an aspect of the practice and can be modified as necessary for your use.

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Single-use, change notification: BioPhorum change notification levels and decision tree – biomanufacturer letter template

Single-use, change notification: BioPhorum change notification levels and decision tree – supply partner letter template

Jul 2019 |

One of the key aspects identified as part of  change notification best practice is good, clear and timely communication. Each company must take responsibility for communication around individual changes following its own practices and policies. The,BioPhorum Change Notification team believe that for the sake of clarity it would be good for each organization that has implemented key aspects of these best practices to communicate this to their customers and/or suppliers.

The templates provided below are provided for use in communicating engagement with an aspect of the practice and can be modified as necessary for your use.

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Single-use, change notification: BioPhorum scorecard survey

Single-use, change notification: BioPhorum scorecard survey

May 2019 | , ,

For change notification practices to realize value the team recognized it is important that a critical mass of biomanufacturer and supply partner companies commit to and implement the same practices as others in the single-use ecosystem. The target was for 15 biomanufacturer companies and seven supply partner companies to implement these practices by the end of 2019, to create critical mass and a working system. The annual scorecard survey is a tool used to monitor the overall effectiveness of change notification for single use systems within the bioprocessing industry. The results from 2018 can be viewed here.

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Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

Single-use, change notification: A guide to the classification of changes to SU manufacturing systems

Sep 2018 | , , ,

The biopharmaceutical industry is increasingly dependent on the use of single use systems to enable manufacturing. These systems are often customised and built from many parts, from a range of component suppliers. Change notification and change management in this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides guidance on the classification of changes, helping those implement the best practice establish consistency in their teams and thereby helping them adopt the change notification practices more effectively. Adoption of these practices enables your company to connect more effectively with the global supply chain and avoid the impact and delay from misunderstood change notifications

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Single-use, change notification: Guidance and implementation tool kit

Single-use, change notification: Guidance and implementation tool kit

Jun 2018 | , , ,

The biopharmaceutical industry is increasing dependant on the use of single use systems to enable manufacturing. These systems are often customized and built from many parts, from a range of component suppliers. Change notification and change management it this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides a definition of best practices that once adopted across the ecosystem will deliver an effective and harmonized change notification system between companies. Specifically it provides an understanding that all companies should categorize changes,standardizes content of a pre-notification and a notification and provides a reporting template, and workflow

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Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

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The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

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Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

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Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges. To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

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The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

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BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, Filing and Review, Interactions with Health Authorities, and Harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

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The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

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BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

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There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

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The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

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With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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Why 100% visual inspection does not mean 100% defect detection
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How to bridge the data integration gap between sponsors and contract organizations
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Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics
Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and... read more

Supply Chain to Patient has launched!
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Electronic data exchange – the foundation for an efficient, resilient inbound supply chain
The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice... read more

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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

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Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

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BioPhorum Deliverables Report
BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Single-use systems
Sterile Filtration QRM & PUPSIT
Information Technology
Digital integration of sponsor and contract organizations
Digital plant maturity model
IT for cell and gene therapies
Lab of the future
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