Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the Agency is still wrapping its head around. Accordingly, on June 22, 2017, FDA announced the availability of a public docket (FDA-2017-N-2697) to collect comments and recommendations on the issue of continuous manufacturing. FDA is seeking public comments on an array of areas, including control strategy, facility, and process validation considerations for continuous manufacturing of solid oral dosage forms, which were areas of focus previously raised with the Agency as part of an industry-coordinated best practices document submitted by the Engineering Research Center (ERC) for Structured Organic Particulate Systems (CSOPS). FDA is also seeking comments on other previously published continuous manufacturing documents, including Regulatory and Quality Considerations for Continuous Manufacturing: May 20-21, 2014, Continuous Manufacturing Symposium.
This is an opportunity for companies to weigh in on the policy, science, technology, and practices that FDA is considering with regard to continuous manufacturing. It is also an opportunity for industry to educate the Agency on some of the practical realities companies are facing when it comes to continuous manufacturing.
Hogan Lovells is happy to answer any questions you may have regarding FDA’s call for comments and to assist with the development of such comments. Comments are due to FDA by September 21, 2017.