FDA Lauds St. Gallen's Findings On 10 Metrics For Ensuring Drug Quality
Executive Summary
US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.
You may also be interested in...
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams
Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.
Providers Support FDA Quest For Public Drug Manufacturing Quality Ratings
Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.