A series of member only downloads which look at industry experiences of the BioPhorum Isolator Good Operator Practice Team
Industry experiences from BioPhorum Isolator Good Operator Practice Team
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glove management
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Isolator glove management evaluation of regulatory guidance and framework of recommendations
Jan 2020 | Annex 1, Fill Finish, POI - Fill Finish
The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.
