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BioPhorum’s revised and improved guidance on single-use change notifications

Changes to critical, complex systems in our regulated environments must be 100% right. This was recognized by the single-use industry and key customers some five years ago and resulted in a number of papers and much better alignment to a standard language and ways of working around single-use system change controls. However, there is always room for improvement and greater alignment in the industry, and the collective learnings have now been...

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How to bring clarity to the testing, validation and release of single-use systems

In the rapidly evolving area of single-use systems (SUSs), the testing of components is critical for process and product quality. However, industry currently faces some critical questions, such as when is it appropriate to rely on vendor testing data? And when should the end-user carry out testing? With this uncertainty also comes the question of whether current regulatory guidance is sufficient? Unfortunately, the answer to this question is...

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

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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Single-use: Testing, validation and release (TVR) standards

When testing single-use items, at what point is it appropriate to leverage vendor data, and when does an end user need to carry out testing? Is current regulatory guidance clear and sufficient in the fast moving area of disposables? And wouldn’t it be great if we had a tool that gave the industry a harmonized risk based approach to testing requirements.  These are the questions that the BioPhorum Drug Substance TVR team have been...

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Extractables testing of polymeric single-use components used in biopharmaceutical manufacturing

This revised extractables protocol for polymeric single-use components in biopharmaceutical manufacturing is based on an extensive scientific review and represents the combined opinion of the biopharmaceutical manufacturers and, crucially, the supply chain. It will reduce costs and focus people on the important data points. The protocol provides guidance on the suggested methods for extractables studies, including sample preparation, extraction conditions, recording test-article sampling conditions, and reporting data from the analysis of extracts. Flexibility is built-in, allowing suppliers to alter many study parameters due to restrictions based on the use of SUS, physical form factor, chemical compatibilities, etc.

The new protocol includes significant changes to the 2014 version, including the removal of 5M sodium chloride and 1% Polysorbate 80 as extraction solvents, the elimination of the time-point zero interval, and the elimination of elemental analysis of 50% Ethanol extracts.

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Extractables: Single use supplier extractable reporting pack

Consistent reporting and presentation of extractable data by suppliers is critical to the fast and reliable assessment of single use systems by users for new solutions. The BioPhorum approach to reporting and presenting extractable data is now the industry standard and adoption of this approach enables all single use suppliers to fit together in an industry ecosystem that effectively supports the continued growth of adoption of single use technologies in biopharmaceutical manufacturing. This pack contains a guide and documents to help single use suppliers and integrators set up their webpages papers and present their extractable data in a way that aligns with the industry standard and extends the ecosystem. Once implemented this approach enables integrators and biomanufacturers to build an extractables profile for a system without needing to transcribe the data, saving time on new designs and minimising the need for expensive custom extractable studies.

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

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 – supply partner letter template

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: A guide to the classification of changes to SU manufacturing systems

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

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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