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The Quality Lowdown: Coronavirus Prompts EU To Extend Comment Deadline For Annex 1

 
• By Joanne S. Eglovitch

Industry gets time to craft more objections to EU GMP PUPSIT provision, excipient data integrity advice offered, FDA MAPPs revised, US hits Health Solutions while EU hits Dishman Carbogen, and 11 added to FDA drug GMP import alert.

The Quality Lowdown

The European Commission has decided to delay by two months the deadline for commenting on the proposed revision to EU GMP Annex 1, giving manufacturers more time to digest some of the changes.

Meanwhile, the US Food and Drug Administration's Center for Drug Evaluation and Research revised several staff manuals that cover coordinating reviews for its Emerging Technology program ETP), coordinating product quality reviews for biological products, clarifying the setting of impurity threshold limits for

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