Inspection reveals QbD-minded FDA

API maker Hovione, following a successful FDA pre-approval inspection of its manufacturing plant in Macau, near Hong Kong, notes that "the FDA is looking in far greater detail to aspects like Quality by Design and supply chain management." The regulator scrutinized preventive and corrective action implementation and follow-up, as well as water systems operation, according to a Hovione announcement.

Under what the company calls the "new FDA approach," inspectors examining the softened water system looked at its design, operational and performance qualification, as well as the previous year's annual report to judge system performance. "But on top of this they expect permanent monitoring of several operational parameters of the system, municipal water quality, and performance of the municipal water system."

QbD, despite great expectations for streamlining the regulatory approval process, has proven itself not much of a headline-grabber. Its development both within the FDA via its QbD pilot and outside of the regulator's domain sometimes appears slower than that of industry standards. But then an announcement like Hovione's or, as reported earlier, a Genentech conference presentation, show that progress is being made behind the scenes.

- see the Hovione release
- here's our Genentech/FDA pilot coverage

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.