We seem to be fully in the swing of industry conferences. This week is the pharmaceutical and biotech manufacturing industries’ INTERPHEX conference in New York City. It: …brings over 11,000 global industry professionals and 650+ leading suppliers together to “Learn It, Experience It, Procure It” through a combination of no cost technical conference, exhibits, demonstrations, […]
Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity […]
ARC Advisory Group’s Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here’s the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the information and automation technologies employed in the plant), is not new, but the relationship is intensifying. What is […]
Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as: …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for […]
It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]
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