Traditional manufacturing practices have served the biopharmaceutical industry well for years, but times are changing and a need for speed to market in life sciences while reducing manufacturing costs is putting a focus on enabling real-time release (RTR)....
We have witnessed an incredible change the last few years in how life sciences manufacturers deliver treatments. Today’s focus is on fast results, and that means products patients rely on cannot sit on shelves for weeks or months waiting on quality validation. In a...
Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing...
The integrity of the data behind the production of pharmaceutical products is paramount. In recent years, the U.S. Food & Drug Administration (FDA) has increasingly observed data integrity related Current Good Manufacturing Practices (CGMP) violations during CGMP...
The pharmaceutical and biopharmaceutical industries have been interpreting recent FDA draft guidance—Data Integrity and Compliance With CGMP Guidance—and exploring new areas such as continuous manufacturing. The Emerson Life Sciences team has a full program of forums,...
Author: Michalle Adkins I often get asked, "So, what do you do for a living?" Boy is that a loaded question. When I say that I manage a group of Life Sciences Industry Consultants for Emerson—that really does not help to answer the question. Hmmm, how do I describe...
Pharmaceutical and biotech manufacturing processes are complex and require well integrated and documented flows of information from upfront forecast demand and customer orders through the production process to inventory receipt and order fulfillment. The components...
Last week, the 2nd International Summit on GMP, GCP & Quality Control was held in Chicago, Illinois USA. Emerson's Heather Schwalje, a senior Life Sciences consultant, presented Moving beyond part 11; Quality assurance considerations for translating Current Good...
Highly regulated industries, such as pharmaceutical and biotech manufacturing, face a myriad of compliance issues, which vary by region of the world and continuously involve. Emerson's Heather Schwalje presented Regulatory Drivers- GMPs 21st Century to Life Science...
It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry - Process Validation: General Principles and Practices. I caught up with Emerson's Heather Schwalje, a senior consultant on the Life Sciences industry team....
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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.