FDA and EU Extend QbD Pilot Program and Continue to Clarify Expectations for QbD
This article was originally published in The Gold Sheet
FDA and EU regulators have announced a two-year extension of the QbD joint review pilot program and are continuing to harmonize their approaches to QbD in a series of recent guides. In one change regulators said that they will no longer accept the use of the term “key process parameter” in assessing criticality because of the misuse of the term.
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