In focus in IPQ’s international coverage for January are the latest developments in the effort by the ICH Q11 Expert Working Group to craft a viable drug substance guideline, which is nearing the Step 2 publication finish line.
Q11 has presented challenges in the elements it is trying to balance – encompassing both development and manufacturing, traditional and enhanced approaches, small chemical and complex biologic molecules, and general principles and CTD submission expectations. Included in our Monthly Update are three stories focused on how the EWG is meeting those challenges regarding: ● lifecycle/change management and control strategy ● manufacturing process development for biotech products, and ● process validation, respectively.
In Europe, we focus on the impact ICH Q9 and 10 is having on the EU’s rewrite of its GMPs on: ● documentation (Chapter 4) – where the expectations have been broadened to fit a quality systems framework, and ● Annex 11 on computer systems – to bring risk assessment into the design and lifecycle decision-making processes.
In the US, FDA concern about complaint investigations and the implications for marketed products was again a driver in a pair of GMP warning letters issued in late January. One of the letters was issued to Baxter – the third big pharma company, along with McNeil and GSK, whose compliance problems in Puerto Rico have drawn attention recently.
Coincidentally, the second letter went out on the same day to Scientific Protein Labs – the supplier to Baxter of the OSCS-contaminated API implicated in the 2008 heparin crisis. The SPL letter sheds light on FDA’s preoccupations in its wake.
Also on the GMP front, McNeil announced another recall – this time stemming from cleaning concerns uncovered during the multi-facility review it is conducting under its “Comprehensive Action Plan.”
On the CMC side, a forum was held in Washington, DC, in January to bring industry and regulator experts together to assess how we have advanced in our understanding of biotech particles and aggregates and the analytical and safety issues they pose. In the first of our stories to come covering the forum and the WCPB conference that followed, we report on the insights that emerged on the challenging issues around the immunogenicity of aggregates.
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