To kick off the New Year, IPQ is providing a compilation of the ten stories that generated the largest readership in 2012.
The most widely read of IPQ’s offerings during 2012 was its special report this fall on “The Current Crisis in Pharmacy Compounding and its Implications.” The dimensions of this major gap in sterile processing control and oversight, which reach across the regulatory, legislative, political and health policy arenas, and the tragic health consequences across the US, led IPQ to produce the in-depth report. We made it broadly available to help in understanding and addressing the crisis (non-subscribers can also access the full special report through the link provided below).
Sterile processing by traditional drug and biotech manufacturers was also in the compliance limelight during 2012. Drawing the second most attention was IPQ’s coverage of insights from FDA compliance officials on: why the agency is so concerned with conventional aseptic processing lines, and where the concerns lie; the repercussions of non-compliance, including drug shortages; and the solutions that technology offers.
In third place on the top ten list is IPQ’s coverage of the insights from an FDA field office compliance veteran on what the agency is currently looking for in responding to FDA 483s. The attention the story drew is reflective of the importance and the challenge of the inspection interaction process.
The top ten list as a whole reveals the prominence of the developments in the generic drug regulatory arena during the year. Along with the GMP compliance problems plaguing the generics industry and their impact on drug availability, particularly among injectables, the stories on the list address the bolus of initiatives FDA has launched to create a more efficient and effective ANDA review process – supported by newly enacted user fees and undergirded by ICH QbD principles. There are implications in this generic drug regulatory enhancement effort that extend across the drug and biotech CMC/review and GMP/inspection spectrum, as the IPQ coverage explains.
Also among the top ten read IPQ stories for 2012 was our coverage this spring of a compelling cautionary tale being told by Genentech of a pair of contamination events that they experienced in their Rituxin cell culture process with the bacteria Leptospira. There is a lot to learn from the biotech manufacturer’s intensive investigations into the causes of the problem and the firm’s efforts to protect against its recurrence. Our story in February about lessons learned by Genzyme from its viral contamination problems also drew heavy attention.