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...
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