Panel led by Pharmatek President, Tim Scott at Outsourced Pharma West discussing FDA Quality Metrics featured on OutsourcedPharma.com
A panel discussion led by Pharmatek’s President, Tim Scott at the Outsourced Pharma West conference held in San Diego & San Francisco this past Summer/Fall was featured on OutsourcedPharma.com. The article titled, “FDA Should Make ‘Quality Metrics’ Public,” by Louis Garguilo, Executive Editor of Outsourced Pharma, discusses how the topic of quality metrics spurred from an original panel discussion at the San Diego Outsourced Pharma Conference this past August. Based on the panel discussion it was decided that the CROs/CMOs should take the FDA up on it’s request for Quality Metrics Guidance and draft up guidelines for evaluation and consideration.
“Whether or not you agree with the FDA in its determination to collect “quality data” directly from all drug manufacturers – including contract manufacturing organizations (CMOs) – if the agency moves forward, then the real question is this: Should that data, and any rating the agency might assign to individual manufacturing plants for quality standards or “quality culture,” be kept internal at the FDA or made public?” Excerpt from article by Louis Garguilo, Executive Editor, Outsrouced Pharma.
To read more from this article visit: http://www.outsourcedpharma.com/doc/fda-should-make-quality-metrics-public-0001Leave a reply →