Drugmakers Urge Changes to FDA Draft Guidance on Continuous Manufacturing

June 10, 2019

Drug manufacturers and trade groups are calling for modifications to the FDA’s draft guidance on continuous manufacturing quality considerations.

In comments posted to the docket, some drugmakers and drug associations urged the FDA to think carefully about the draft guidance. GlaxoSmithKline, Europe’s Active Pharmaceutical Ingredients Committee (APIC), and the International Pharmaceutical Excipients Council of the Americans all pointed out, for instance, that the International Council for Harmonization guideline on the same topic—ICH Q13—is pending.

GSK criticized the guidance’s flow, arguing that GMP and regulatory topics frequently appear together and may be confusing in respect to the expectations for submissions versus GMP control. The drugmaker also said the guidance offers scarce information on using continuous manufacturing to simplify areas like validation to reduce drug costs and resupply times.

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