FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Drugmakers Ask for Choice Between Product and Site Quality Metric Reports

March 1, 2017
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Companies want a choice between providing quality metric reports on either a product-by-product or a site-by-site basis.

An FDA official offered an update on the agency’s reissued draft guidance for quality metrics — and discussed stakeholder comments — at a conference on manufacturing quality this week.

Both types of reporting have their benefits, according to Tara Gooen Bizjak, senior policy advisor for pharmaceutical quality at CDER, who spoke Tuesday at the Parenteral Drug Association’s Pharmaceutical Quality Metrics and Quality Culture Conference in Bethesda, Md. Some companies prefer the product-wide approach because the segmentation of site-by-site reporting can obscure the big picture, she said. However, site reports have the benefit of being less burdensome.

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