The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

Drugmakers Ask for Choice Between Product and Site Quality Metric Reports

March 17, 2017

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An FDA official offered an update on the agency’s reissued draft guidance for quality metrics — and discussed stakeholder comments — at a conference on manufacturing quality this week.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

The FDA draft guidance specifies three primary quality metrics for drugs: the lot acceptance rate, the rate of invalid out-of-specifications and product quality complaint rates. A senior management commitment to quality culture is also essential, because it “provides a foundation as much as data integrity does,” Bizjak said.

“Context matters” when it comes to quality metrics, and proper enforcement must take the full context into account rather than zeroing in on individual data points, she said. For example, when determining invalid OOS rates, FDA officials should factor in the lab’s total number of tests performed to contextualize the data for industry-wide comparison.

FDA plans to launch a quality metrics reporting electronic portal in early 2018 and, in the long term, hopes to coordinate the reported information with its own data.

The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls — you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls. Order Three Phases of QSR-Compliant Equipment Control and understand the QSR requirements for the installation, operation and maintenance of your manufacturing equipment.