NEWS

Quality, safety, and cost benefits with BioPhorum’s supply change notification template

30 August 2022
Supply Partner
BioPhorum

Supply change notifications across the biomanufacturing industry have increased significantly since the start of the pandemic due to the increased requirements for raw materials used in the vaccine manufacturing process. One BioPhorum member has reported an increase from two notifications a week to 200 a month.

Unfortunately, this surge has highlighted inefficiencies in the change management process for single-use systems (SUS) and its ability to handle the increased volume of information. It is a frustration across many BioPhorum members.

Yet, the vast increase in notifications is only part of the problem – incomplete data in a non-standard format, together with the low adoption of BioPhorum’s SUS change management guidelines (see below), makes it difficult for the notification receiver to effectively process the change. There is also no consistent way of bundling change notifications together.

Now is a perfect time to review how this process is managed across the industry and add more rigor to the practice by proposing that communication of the required content and information is made mandatory.

In response to this proposal, BioPhorum has produced a Supply Change Notification Template, which will allow suppliers and customers to exchange the right information at the right time.

It will help standardize this important industry function and ensure that the minimum required information is created and shared. This may require some additional effort for the creator but will result in an agile process and reduce re-work, time, and delays further along the process.

Multiple benefits
Implementing this template will have quality, safety, and cost benefits ranging from better right-first-time information and a standard way of working to reduced delays in qualifying a change and strengthened end-to-end supply chain relationships.

The template has been designed to allow attachments and links to be added and reduce duplication of effort if information exists elsewhere. It is based on BioPhorum’s Single-use, change notification: A guide to the classification of changes to SU manufacturing systems and Change Notification: A guide to change notification packages for single-use manufacturing systems.

If this situation is not resolved, existing problems will continue to create waste that impacts people, resources, time, and cost – it may even have a greater impact on the supply chain and delivery of the end product to patients. The effect of not having a standard process includes:

  • The receiver cannot process changes efficiently, often due to a lack of clarity or enough information being provided – this leads to a poor understanding of the change impact and so presents a risk to delivery
  • The sender may often have to re-work or provide extra information to confirm or check missing data – the receiver may then have to ask repeated questions to clarify information as it is drip-fed.

This template is an example of BioPhorum working toward best practices and standards for SUS supply change notifications and improving the flow of process data up and down the supply chain. It is a real template for succ

DNA Strand & Digital Earth
NEWS
BioPhorum’s patient-centric framework for developing the inbound supply chain
Data On A Spreadsheet
NEWS
New value-add tools to complement BioPhorum’s forecast and demand planning toolkit
Improving Supply Chain Quality Management Through A Common Language
NEWS
Improving supply chain quality management through a common language

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