Jerry Lanese
The Lanese Group, Inc., USA
Title: Turning the FDA quality metrics into a proactive quality improvement tool
Biography
Biography: Jerry Lanese
Abstract
In July of 2015 the FDA issued draft guidance –Quality Metrics. In this guidance the FDA informed the industry that it plans to have all firms that manufacture an API or drug product for distribution and sale in the United States to submit data that the Agency will use to calculate defined quality metrics. In reality, the FDA will be requiring the firms to review the type of data that they should have been reviewing since the 1978 release of the current GMPs. The FDA indicates that they will use the data and calculated metrics to plan a risk based inspection schedule. The firms should take this opportunity to use to identify systemic problems and monitor the effectiveness of elements of the quality system. However, if the firms collect and submit the data and calculate the same quality metrics that the FDA will be calculating in the time frame discussed in the draft guidance, they will be evaluating data up to a year old and the indicators will be lagging. Pharmaceutical firms should establish programs that proactively use the data they will have to collect for the FDA, the calculated metrics, and other appropriate data as leading indicators of problems and apply the enablers of the Pharmaceutical Quality System: Quality Risk Management and Knowledge Management to support the elements of the Pharmaceutical Quality System: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action (CAPA), Change Management System, and Management Review to support their program of continuous improvement.