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

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

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

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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Change notification: Stakeholder analysis – supply partner

Change notification: Stakeholder analysis – biomanufacturer

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 – 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: BioPhorum scorecard survey

Single-use, change notification: BioPhorum scorecard survey

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

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

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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