The detection and segregation of non-conforming materials and the justification of sampling plans and locations will be key regulator concerns in reviewing the control system for continuous manufacturing (CM) operations, Vertex is advising based on its experience as the first company to have gone through the CM clearance process at FDA.
Vertex experts also emphasize the importance of redundant process analytical technologies (PAT) and early discussion with regulators on control system challenges to make sure that the CM development program is on track.
Vertex received FDA approval for Orkambi (lumacaftor/vacaftor), a fixed dose combination tablet product for cystic fibrosis, in June 2015, and has now had time to assess its engagement with FDA and other regulatory agencies in view of how the regulatory concerns have played out in its post-approval manufacturing experience.
Regulatory Affairs Senior Director Stephanie Krogmeier and CMC Quality Director Sue Miles are among those involved from Vertex who have been providing insights on its experience and learnings at recent conferences. The insights are instructive on the pathway to getting new manufacturing technologies accepted globally.
At the PDA/FDA conference in September 2016, Miles accompanied CDER Office of Pharmaceutical Quality (OPQ) Director Michael Kopcha at a session addressing CM and other advanced manufacturing technologies. Krogmeier presented alongside OPQ Office of Process & Facilities Division of Process Assessment II Director Sharmista Chatterjee and Bristol-Myers Squibb (BMS) Associate Director Tim Stevens at a CM session at the AAPS annual meeting in Denver Colorado in November.
[Editor’s Note: A review of the regulatory perspectives provided on CM by Kopcha and Chatterjee are provided in the February/March 2017 IPQ Monthly Update. A second story in the issue addresses how CM is driving a stronger focus on fit-for-purpose excipients. For more on CM’s progress down the regulatory clearance and implementation pathway see IPQ’s February/March 2016, June 2012, and February 2011 Monthly Updates.]