PDA Pharmaceutical Quality Metrics Conference Offered Industry and U.S. FDA a Forum to Discuss Future Risk-Based Inspection Program 5 December, 2014

Washington, D.C. (December 4, 2014) – The Parenteral Drug Association (PDA) today closed its second annual Pharmaceutical Quality Metrics Conference with panels of distinguished representatives of pharmaceutical companies and officials from the U.S. FDA, the European Medicines Agency and the UK's regulatory body for medical products. Nearly all of the conferences 250 attendees remained engaged through the final panel discussions Thursday.

The PDA conference represented the first time the European Medicines Agency commented on FDA’s quality metrics program. The EMA representative noted that European inspectors collect quality metrics data during inspections, but not in advance and that comparing metrics across companies/product lines is difficult because of regional differences. However, the European officials applauded the FDA effort and indicated that they are closely watching the situation. They expressed hope that eventually a harmonized approach can be reached so companies are not overburdened with having to provide different sets of metrics to different agencies around the world.  The 2014 workshop also took on the difficult task of defining quality culture, and possible objective metrics of culture in a pharmaceutical manufacturing environment. The dialogue from the workshop, combined with the results of the survey, will factor into a future PDA paper that will help companies evaluate the strength of their quality cultures.

U.S. FDA officials set up the dialogue in the first few plenary sessions by presenting quality metrics that could help inform the Agency’s risk based inspection model.   

The subsequent dialogue sessions provided industry participants an opportunity to comment and offer feedback on aspects of quality culture metrics as well as the FDA proposal. 

PDA provided electronic voting devices in multiple breakout dialogue sessions, facilitated by both an industry and U.S. FDA representative, for the collection of audience feedback on a number of questions related to quality culture behaviors,  possible quality culture metrics, and the FDA proposals. 

Following what many attendees called this opportunity to “speak up” on quality metrics, FDA retook the podium on Wednesday in an ad hoc plenary session to re-explain its position on quality metrics. FDA stressed that pharmaceutical quality metrics gathered under the authority of the Food and Drug Administration Safety and Innovation Act will be used as intelligence by the Agency during a structured review process and not drive regulatory action. A key objective for the Agency gathering this additional data is to address drug shortages. Such metrics, which PDA and other industry groups have helped define over the last year, will help FDA allocate its limited inspection resources towards companies at the greatest risk of noncompliance.

FDA plans to compare metrics across products and manufacturing sites.

The conference closed with two different panel discussions. The first included quality professionals from several branded and generic drug companies. The last panel was composed of officials from various FDA divisions and representatives from European regulatory bodies.

Conference participants appreciated the open dialogue and left with the strong understanding that culture matters to product quality and that much more work remains to be done to determine the best ways to foster and support a strong quality culture across all sectors of the pharmaceutical  industry.