The fifth version of ISPE’s The Good Automated Manufacturing Practice (GAMP 5) Guide for Validation of Automated Systems in Pharmaceutical Manufacture represents the most recent and updated tool in the approach for the validation of GxP computer systems. If computer systems employed in the pharmaceutical industry do not follow GAMP 5 guidelines, they have a risk of non-compliance with FDA’s directive 21 CFR Part 11.
Fifteen years ago, Able Laboratories was one of the top producers of generic drugs. But that was before FDA investigations. Following audits in the 2000s, the Food and Drug Administration discovered that the company had falsified documents in order to market potentially dangerous drugs. Today, Able Laboratories is history, and an example of what non-compliance with FDA regulations can lead to.
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