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01.14.21 Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues
This report helps biopharmaceutical companies make more informed CMO decisions and helps CMOs optimize operational and marketing strategies. ISR presents data on 509 service encounters from 179 respondents who have been involved in outsourced biologics API projects in the past 18 months. Learn more here.
Featured Editorial
By Andrew Walsh, Ralph Basile, Ovais Mohammad, Stéphane Cousin, Mariann Neverovitch, and Osamu Shirokizawa
The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA s new Q&A 7 and Q&A 8.
The Evolving Role Of The GxP Archivist
By Stuart Ward, Bob McDowall, Damien Tiller
This need to protect the data encompasses intellectual property and/or regulatory data integral for marketing submissions. Therefore, ensuring the archivist can guarantee adequate protection and control for regulatory data is critical for organizations to meet their business goals. According to the AGIT Guidelines for the Archiving of Electronic Raw Data in a GLP Environment published in 2018, “the archivist is responsible for all aspects of electronic archiving and should have full control of all activities within the archiving process. If there is external IT involvement (e.g. a service provider), the