BRIEF—Drugmakers slam FDA draft guidance on continuous manufacturing

Drug manufacturers and trade groups are calling for modifications to the US Food and Drug Administration’s draft guidance on continuous manufacturing quality considerations, according to a posting by WCG Marketing Intelligence & Insights.

UK pharma major 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 Good Manufacturing Practice (GMP) and regulatory topics frequently appear together and may be confusing in respect to the expectations for submissions versus GMP control. The company also said the guidance offers scarce information on using continuous manufacturing to simplify areas like validation to reduce drug costs and resupply times.