Request for Quality Metrics

PDA is concerned that there remain questions on metric definitions/data points and logistics that need to be resolved before companies can prepare data for submission during the voluntary phase. PDA believes an additional Question and Answer document addressing the comments received to the revised draft will further help to clarify the request and encourage firms to participate in the voluntary phase of submitting data. To that end PDA has enclosed a listing of all the questions collected from participants at the 2017 PDA Metrics and Culture Conference. PDA would like to emphasize that the FDA consider the importance of the trends of each of the calculated metrics rather than compare individual results from one plant site or one company to another. As noted in previous PDA comments to the original draft guidance, because of the great diversity across manufacturing operations and product types, a straight comparison of data points may not provide valuable or operational information for the risk based model of inspections. PDA's detailed comments on the draft guidance are attached.

PDA appreciates the involvement FDA has had with industry stakeholders on the development of the Quality Metrics program over the last three years. PDA agrees with FDA that the key drivers of the quality metrics program are to enhance pharmaceutical product quality and prevent drug shortages for patients by allowing FDA to focus compliance resources on high risk establishments and to reduce regulatory burden of onsite inspections and prior approval changes for those sites deemed low risk based on FDA's risk-based inspection model. PDA's detailed comments on the draft are enclosed.