QbD process steps studied in regulatory pilot

Regulators on both sides of the Atlantic are collaborating with a focus on the process end of new drug applications. The FDA and EMA are planning a co-review pilot for drug candidates developed using Quality by Design methods.

QbD relies on statistical, analytical and risk assessment methods that are as yet unproven through lack of application in their ability to produce safe and efficacious drugs. Pharmtech reports that regulators still have questions about such QbD concepts as design space, real-time release testing and continuous processing.  The pilot began last month and will run three years.

Through another pilot begun in late 2009, U.S. and EU regulators are conducting joint facility inspections. Early reports suggest that inspectors usually agree on inspection results.

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