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The Quality Lowdown: US FDA Finding New Crop Of Data Integrity Problems

 
• By Joanne S. Eglovitch

Manufacturers warned to keep better electronic records and not falsify data in recent warning letters, ICH adds three residual solvent limits for pharmaceuticals, and the Polish authority hits firm for GMP noncompliance.

The Quality Lowdown

The US Food and Drug Administration’s recent warning letters to drug manufacturers and active pharmaceutical ingredient manufacturers in the US and India show that data integrity problems are not going away anytime soon, despite the inspection hiatus that was brought on by the coronavirus pandemic.

Also, the International Council on Harmonization proposes to add three new residual solvents to the list of solvents considered safe in pharmaceuticals in a Step 2 guidance.

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