CDER Offering More Concrete Advice on Continuous Manufacturing as Experience Grows

FDA’s Office of Pharmaceutical Quality (OPQ) has gained enough experience in interacting with industry on implementing continuous manufacturing (CM) operations to be able to offer more concrete advice on the considerations that warrant extra attention.

One of OPQ’s primary objectives is to encourage the development and adoption of emerging technologies, and the office has been expressing strong support for CM both from the podium and in its interactions with individual companies moving down the CM pathway (see IPQ’s Feb./March 2016 Monthly Update for a full review of OPQ and its piorities).

However, with the regulatory greenlight for CM confirmed in practice and a growing body of experience, OPQ is now also offering substantive advice on how to avoid obstacles and make the development, clearance and implementation process as smooth as possible.

Early communication and collaboration with the agency is an important enabler, as both OPQ Director Michael Kopcha and OPQ Office of Process & Facilities (OPF) Division of Process Assessment II Director Sharmista Chatterjee have emphasized at recent conferences in discussing the benefits and challenges of transitioning to CM.

At the PDA/FDA 2016 conference held in Washington D.C., Kopcha offered a broader overview of the power of continuous manufacturing and other advanced technologies to help address the agency’s regulatory concerns and improve product quality. His talk encompassed: ● OPQ and quality trends ● modernizing manufacturing with CM ● the challenges and opportunities in CM, and ● the agency’s approach to addressing CM.

Chatterjee honed in on the regulatory considerations when converting batch processes to continuous manufacturing and how collaboration with the agency can help clarify and address them at the AAPS annual meeting in Denver in November 2016.  She addressed: ● the drivers for switching from a batch to a continuous process ● considerations when making this switch ● regulatory expectations for the submission, and ● the site-specific preapproval inspection considerations.

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