In a U.S. Food and Drug Administration’s FDA Voice blog post, FDA Budget Matters: Investing in Advanced Domestic Manufacturing, FDA Commissioner Dr. Scott Gottlieb opened noting: Advanced manufacturing, which includes various technologies, such as continuous manufacturing and 3D printing, holds great promise for improving the American market for drugs and biologicals. Emerson’s Ron Rossbach shared […]
When it comes to benefitting from new technologies, pharmaceutical and biotech manufacturers often feel constrained from implementing changes due to possible revalidation regulatory requirements. In this short 1:52 video, Industry 4.0 in Life Sciences, Emerson’s John Nita explains how technologies such as Industrial Internet of Things (IIoT) technologies have actually been around longer than the […]
Author: Zuwei Jin Among all of the important trends in life sciences industry such as modular plants, integrated modules, out-of-box smart factory, single-use equipment, PAT, and manufacturing execution systems (MES), IIOT has been receiving high interest including among pharmaceutical and biotech manufacturers. It is our view that the same technology advancement that makes Industry 4.0 […]
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 […]
Powered by WordPress