Data Integrity Lapses Continue To Bedevil Manufacturers
This article was originally published in The Gold Sheet
A recent compilation of FDA warning letters shows that data integrity failings continue to plague API and finished drug manufacturing sites in Asia and Europe.
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Ipca Laboratories was pummeled on Indian bourses after the US FDA barred all but one product from three of its facilities that have been grappling with compliance-related issues, piling up more pressure on the firm.
With data integrity problems on the rise, pharmaceutical manufacturers must ensure in auditing their contract manufacturing partners that they have the robust electronic controls needed to survive an FDA inspection. The analytical lab is a good place to start when doing audits because it's where a majority of problems are found by FDA investigators.
Data integrity warning letter to Chinese API maker reflects continuing focus of FDA enforcement efforts on the pharmaceutical industry's Asian supply chain.