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.
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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...
The BPOG DS reliability workstream has developed guidance enabling member companies to optimize their maintenance and calibration frequencies by assigning the correct ‘trigger’ for these activities. The guidance describes the various tools and processes available, as well as methods to implement change, illustrated by case studies. The Return on Investment (RoI) for optimization of maintenance frequencies is clear – direct reduction of...