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An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems

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This paper strives to provide the requisite background to put the proposed Practice into context, from the perspectives of process, quality and regulatory expectations. Thus, the paper contains sections that describe the team’s collaborative process, and general quality and regulatory expectations of drug manufacturers. We then transition to a discussion of change, best practices for content of pre-change notifications and change notifications, a process workflow and a template that is the unifying tool for our proposal.

Product Details:

Product ID: 13
Publication Year: 2017