Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ).

Beginning with the questions in mind and following up with supporting sampling plans and statistical tools will increase the chances for a successful and compliant PQ effort, agency officials are stressing.

In a presentation on the current FDA and EU expectations for process validation at a PV Interest Group session held at the PDA/FDA Joint Regulatory Conference in late September in Washington, DC, Office of Process and Facilities (OPF) Division of Inspectional Assessment Acting Branch Chief Grace McNally emphasized the importance of framing the PQ questions prior to creating or executing the plan.

OPF is part of the new Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ). McNally joined OPQ from CDER’s Office of Compliance, with the shift in its focus during the center reorganization (IPQ October 26, 2014).

McNally has been a leading policy maker for FDA in the process validation arena. She helped author FDA’s 2011 PV guidance and served as the agency representative on the drafting team for the revision of EU Annex 15, which became effective at the beginning of October (IPQ October 31, 2015).

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