The BioPhorum Extractables team has shown the benefits of great collaboration between biomanufacturers and suppliers – they agreed to significantly reduce extractables testing for single-use systems. This decision was made possible by the supply base’s considerable body of data generated through the existing protocol and the biomanufacturer team’s work over the last 12 months. Similar studies have been performed previously, but typically with a...
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The BioPhorum IT Agile workstream has published a supplementary guide – Agile in GxP Environment: companion document, to be used alongside its original guidance to provide more practical advice on how to implement agile in a GxP environment. The Companion is less about ‘what is Agile’ but more ‘how to do it’ in the biopharmaceutical arena.
BioPhorum EM RA Tool template
An industry-wide standardized methodology and risk classification for particulate classification-REDIRECTED TO DOWNLOAD PAGE
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The Microbial Control team is working on a series of related challenges and driving towards a goal to help all member companies have contamination event free environments as soon as possible. Two detailed areas have been moved forward in the last year, low endotoxin recovery and mold monitoring. Both have been subjects of concern for regulators in recent years and so the group has developed science-based harmonized industry protocols that will...