ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industry’s first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances based on experiential and objective pilot program data.

The ISPE’s Advancing Pharmaceutical Quality (APQ) program proposes an industry-led approach to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The basic framework of the program is to “assess and aspire” quality maturity.

Learn More