ISPE announced in mid-March that it will conduct the industry’s first “Quality Metrics Pilot Program” designed to define standard metrics reporting to FDA. The pilot will test a series of indicators that support an FDA risk-based inspection program. ISPE plans to launch the pilot with workshops for industry education and input, involving FDA participation, during the 3rd Annual ISPE-FDA CGMP Conference in Baltimore, MD, in early June 2014. The pilot will be open to a limited number of sites and product types, and will represent branded, generic, and over-the-counter products, ensuring statistically meaningful findings.
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