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...
data integrity and compliance
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...
Author: Michalle Adkins In April 2016, the FDA issued Data Integrity and Compliance With CGMP Guidance for Industry. This is on the heels of a lot of related 483s, warning letters, and more severe actions with respect to this issue. There are some interesting things...
Stay up to Date with the Latest News and Updates
Subscribe for Updates
We invite you to follow us on Facebook, LinkedIn, Twitter and YouTube to keep up to date on all the latest news, events and innovations to help you take on and solve your toughest challenges.
Our Global Community