Drugmakers Should Look to 483s and Warnings for Lab Control Tips

To avoid getting cited for poor laboratory controls when FDA investigators come calling, manufacturers should study the mistakes made by their peers, one expert says.

Inappropriate or scientifically unsound laboratory controls were cited in 109 Form 483s in 2014, occupying the second spot on the top 10 list. The observation jumped to second place from fourth in 2013 in the annual rankings.

So why has poor laboratory controls moved up? The reason may be behind roughly half of all causes for the observation.

Roughly 50 percent of the lab control observations are doled out due to poor data integrity, says Ludwig Huber, director of the consulting firm Lab Compliance and a renowned laboratory quality expert. The other half of observations are due to poor quality systems and not following proper procedures.

Last year, the FDA started highly scrutinizing data integrity after several egregious violations by international manufacturers involving falsification and destruction of data. Common data integrity issues that wind up as laboratory control observations include not installing audit trails to track who changed a test result and when.

Compounding the problem is the minimal guidance the FDA gives on how to maintain data integrity, specifically Part 11, the section of federal regulations that governs electronic records, Huber says.

With little agency guidance, manufacturers need to look at warning letters and Form 483s to determine what the FDA is looking for during an inspection.

Companies can also hire a consultant to train staff on how to identify and properly secure high-risk manufacturing records such as analytical batch test results.

Manufacturers should incorporate findings from warnings and 483s into their internal audit system so the facility’s processes are being measured against what the FDA is actually looking for, Huber adds.

Internal audits are also crucial to preventing the other main cause of poor lab observations: poor quality systems. The audits should reveal if someone is not following standard operating procedures and why.

“There could be a couple of reasons, such as not having enough time or the procedures are too complicated to read,” Huber says. “Most of the time there is a reason behind it.”

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