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Continuous Manufacturing/QbD Relationship Explored by Industry and Regulators at FDA/PQRI Conference

Feb 26th, 2016

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The impact of continuous manufacturing (CM) on the ability of pharma to fully implement quality by design (QbD) and realize its benefits is becoming clear as the technology moves into full operation.

The potential for QbD to come to fruition in the process understanding- and data-rich environment of continuous manufacturing was highlighted by both FDA and industry experts in the discussions at a conference on “Advancing Product Quality,” cosponsored by the agency and the Product Quality Research Institute (PQRI) in October in Bethesda, Maryland.

Spurring the discussions was the approval in July 2015 of the first drug application encompassing a continuous manufacturing process.

Vertex – a committed proponent of the power of the continuous manufacturing/QbD relationship – received clearance for a tablet for cystic fibrosis, sold under the trade name Orkamb, using the process. EMA approval followed two months later. 

At the FDA/PQRI meeting and others held toward the end of 2015, Office of Pharmaceutical Quality Deputy Director Lawrence Yu highlighted FDA’s ability to review the continuous manufacturing-based application – along with one involving 3D printing – without a delay as a testament to FDA’s commitment to supporting technological advancements (IPQ February 21, 2016).

That support, Yu explained, reflects the agency’s belief that these emerging manufacturing technologies, linked with QbD, can help address the current manufacturing challenges that lead to recalls and shortages.

[EDITOR’S NOTE: In 2011 and 2012, IPQ provided a series of stories exploring the promise of continuous manufacturing in bringing the new QbD-oriented quality concepts onto the shop floor. IPQ’s February 2011 Monthly Update includes two stories providing the vantage point of CDER experts. The June 2012 Monthly Update includes three stories exploring Vertex’s out-front progress down the continuous manufacturing/QbD pathway.]

“A decade ago,” Yu commented, “when people talked about continuous manufacturing, as a chemical engineer, I said, ‘really?  Is this going to happen?’  A decade later, I can tell you that this has become a reality. I know that a lot of companies are actively pursuing continuous manufacturing because the process offers flexibility and robustness.”

[The story continues for subscribers beginning on page 2.  Nonsubscribers can get information on IPQ subscriptions/ licensing and individual story purchasing by contacting Wayne Rhodes ([email protected]).]

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