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FDA Urges Pharmaceutical Industry to Dig Deeper in CMO Audits

This article was originally published in The Gold Sheet

Executive Summary

To ward against potential data integrity problems, an FDA official warned the biopharmaceutical industry against conducting “superficial” audits of their contract manufacturing organizations and suppliers. An increase in outsourcing is corresponding to a similar growth in data integrity problems, an FDA official told a recent industry meeting, while industry discussed best practices on choosing and working with CMOs.

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