Extensive Vetting of FDA’s Draft Process Validation Guidance Smoothes Its Transition to Final Form

The extensive vetting process on FDA’s draft process validation guidance confirmed to the agency that only a relatively few clarifications were needed to bring the draft into final form.

The vetting process included a series of workshops at which the agency’s process validation working group met with industry to carefully explain its intentions and get feedback on whether the draft had successfully met them. The agency then put the draft out for written comment and received a healthy amount of additional input.

[Editor’s Note: In late 2009, IPQ released a 44-page special report on FDA’s process validation guidance initiative, which provides an in-depth analysis of the workshop discussions. The report includes a review of the background, context and intent of the new guidance by CDER compliance official Grace McNally, who co-chaired the working group that developed it. Also provided in the report are reviews by key industry experts of each stage of the new validation model.  The full special report can be purchased by non-subscribers for $249 by contacting Karen Bertani (Jonathan@ipq.org).]

The positive reception the draft received reflected its consensus-based development process and solid grounding in the quality-by-design, risk management and lifecycle quality system principles embedded initially in the agency’s 21st Century quality initiative and subsequently in ICH Q8-10.

Based on FDA’s effort to make sure everybody was on the same page and the feedback, the working group did make a handful of clarifications in the final version regarding:  ● the term “criticality” ● worst case conditions ● process performance qualification ● concurrent release  ● legacy products ● viral clearance, and ● facilities and equipment. A glossary was also added reflective of the industry interaction.

[An analysis of the final version of FDA’s process validation guidance and insights by working group cochair Grace McNally on her group’s decision making are provided for subscribers here. Non-subscribers can purchase the full story for $195. The full story will be included with purchase of IPQ’s special report on the agency’s process validation initiative.  For subscription information, click here.]