FDA Quality Metrics - Marci Goldfinger & Anne Pericone Johnson & Johnson

This presentation provides an overview of the evolution of these guidance documents, along with a review of the data elements in the most recent draft guidance and the metrics FDA intends to calculate. [...] • Identify situations in which there may be a risk of drug supply disruption • Improve effectiveness of establishment inspections via risk based inspection approach • Improve FDA’s evaluation of drug manufacturing and control operations 9 Things to Know • Scope: All drug products manufactured OR marketed in the US. [...] • Nov 2016 Draft Guidance: Establishes a voluntary pilot with FDA for data submission (by product or by site) • FDA planning to use results of pilot to move into rule-making 10 When Would Quality Data Submission Begin? In the current Draft Guidance, FDA is asking for: Voluntary product data reports • In early 2018 (January – March)* • Separate reports for API and Finished Drug • Submission of data. [...] • Most systems designed to deliver site metrics • Not as easy to collect product metrics across its supply chain • Industry engaged in the Quality Metrics discussion • …and open dialog with FDA 23 …. [...] Learnings (So Far) • Trending is most important • Optimizing a metric program takes time to evolve • Focusing on a metric can compromise its utility • Finding forward looking metrics is very difficult • Metrics has to be combined with a strong Quality Culture to be meaningful 24 PDA Quality Metrics Task Force • Steven Mendivil (Chair) • Pritesh Patel (Novartis) • Denyse Baker (PDA) • Edwin Rivera-.