Single-use user requirement (SUUR) toolkit

Single-use user requirements how to guide	This presentation, with supporting audio when viewed in presenter mode, guides users in completing the toolkit.
User requirements template	The template is a form that allows end users to communicate process/application details and single-use-system requirements to suppliers and allows suppliers to affirm or describe their capabilities to meet these requirements. It is organized into a logical structure of user-requirement categories and uses consistent and common terminology.
Technical diligence templates	These forms are pre-populated with end-user requests for detailed information that describes how suppliers fulfil specific user requirements. Supplier responses to the request for information may serve as the basis of a technical diligence exercise. These responses will allow end users and suppliers to develop a common understanding of user requirements and supplier capabilities and will allow both parties to make efficient and informed decisions.
Supply chain memo	The template is a form that allows end users to communicate requests for supply chain-related information (e.g. component part number and manufacturer) to suppliers and provides suppliers with a dedicated document to respond to this request.
Industry proposal for implementation of the SUUR toolkit	This presentation sets the context for the SUUR toolkit, aimed at the most senior of sponsors.
Guideline for implementation of SUUR toolkit	This presentation highlights the toolkit fundaments targeted at implementation middle managers.
Guideline for use of SUUR toolkit	This presentation guides users around the toolkit.
How To Guide New for 2019!	Audio narrated over presentation, articulating how to use the core templates.
BioPhorum-BPSA benefits wheel	This poster aims to summarize adoption benefits.
Supplier flyer New for 2019!	This flyer for suppliers aims to be a discussion document between suppliers and their end-user customers on why using the toolkit may be of benefit when designing new SUS systems.

Attached Files

File
1601627011wpdm_Supply chain template September 2020.docx
Supply chain template September 2020.docx
SUUR-Toolkit-Complete.zip

Preview

Download

Version
Download 869
File Size 31.64 MB
File Count 3
Create Date 9th September 2019
DOI
Last Updated

Phorums

Cell & Gene Therapy

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.

Development Group

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.

Drug Substance

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.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

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.

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum.

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.

Regulatory-CMC

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.

Supply Chain to Patient

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.

Supply Partner

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:

an enhanced robustness and resilience
accelerated capability and capacity to effect technology adoption
reduced cost of quality, and
industry-wide alignment on operational implementation

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

Sustainability

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.

Technology Strategy

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.

Building on industry feedback to standardize plasmid release specifications

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

A media fingerprinting toolbox that comes with a host of benefits

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

Why 100% visual inspection does not mean 100% defect detection

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

How to bridge the data integration gap between sponsors and contract organizations

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

Supply Chain to Patient has launched!

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

How are you improving your environmental sustainability performance?

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

Adding value for analytical instrument partners

Single-use user requirement (SUUR) toolkit Single-use user requirements how to guide This presentation, with supporting audio when viewed... read more

MediPhorum

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.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

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

Deliverables

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

Operations

Information Technology

BioPhorum Downloads

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.

Case Studies

Welcome to the BioPhorum case studies page, where you can learn how our clients have used our service to discover innovative solutions and save money. Here you can read real-life stories of how various organizations have used our unique data-driven approach to streamline their processes and make the most of their resources. Whether you're looking for inspiration or want to learn more about the potential benefits of our service, you'll find it here.

Webinars and podcasts

Welcome to BioPhorum Connect, the podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, this podcast brings you the insights and perspectives of experts from around the world. We'll discuss all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. So, join us on our journey as we explore the world of biopharmaceuticals and learn from the perspectives of those at the forefront of the industry.