Posts Tagged ‘Data Integrity and Compliance’

Data Integrity for Pharmaceutical and Biotech Manufacturers

Posted in Life Sciences, Regulatory Compliance on Tuesday, March 13th, 2018. No comments yet
Tags: , , ,

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 […]

Pharmaceutical and Biotech Manufacturing Data Integrity

Posted in Life Sciences on Thursday, November 10th, 2016. No comments yet
Tags: , , , , ,

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 inspections. At the recent Emerson Exchange conference, Emerson’s Michalle Adkins co-moderated the Life Sciences Industry Forum session with […]

FDA Guidance for Data Integrity and Compliance

Posted in Life Sciences on Thursday, April 28th, 2016. No comments yet
Tags: , , , ,

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 to note from this document. The FDA has provided this […]