Why is the Quality Metrics Initiative so important? What are the latest developments?
Following the passage of the US Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA was authorized to collect manufacturing quality data from pharmaceutical companies and obtain certain records from a drug manufacturer in lieu of, or in advance of, an inspection. FDA also was directed to replace the previous two-year drug inspection frequency requirement with a risk-based inspection approach.
The FDA is considering the utilization of quality metrics as an input to its inspection models as well as to predict possible drug shortages, determine inspection schedules for a manufacturer, assess post-market change reporting, and re-structure the format of inspection. To that end, the FDA has invited input from industry on which metrics manufacturers use and find effective metrics to assess processes and their risks.
ISPE has been leading the charge in bringing the pharmaceutical industry and regulators together to create an open dialogue on shaping the Quality Metrics program as it is launched industry wide. This webinar will help you learn more about this initiative and how it is impacting the pharmaceutical industry.
What is ISPE Doing?
ISPE has been at the forefront of gathering clear and objective data through its Quality Metrics Pilot Program.
In 2014 — 2015 the QM team designed and undertook an extensive Pilot Program to test the feasibility of collecting and reporting a standardized set of quality metrics. The primary objectives of the Pilot Wave 1 were to:
- Test the harmonization of definitions for a set of industry metrics that represent both leading and lagging indicators.
- Test the feasibility of centralized data collection across companies at different maturity levels within their own internal metrics programs.
- Explore industry practices in the areas of quality culture and process capability.
- Inform continued industry input to FDA.
Wave 1 of the Pilot met all of its objectives.
- The learnings of the Pilot Wave 1 were shared with industry and regulators at ISPE conferences in April and June 2015.
- A full report on Wave 1 is available in the ISPE Bookstore.
Findings from Wave 1 are enabling ISPE and industry to provide data-driven input to the current FDA draft Guidance.
ISPE Quality Metrics Wave 2 Findings
- Wave confirmed the importance of quality culture, however, quality culture is very hard to measure and is confirmed as extremely difficult using simple-to-collect metrics.
- Wave 2 identified an internal metric, Deviations Recurrence Rate, which could be used by companies to assist with predicting quality outcomes. This metric was found to be hard to define clearly for cross company use.
Findings from Wave 2 contributed to the ISPE response to the FDA Draft Guidance which led to the ISPE recommendation that FDA's program start with a small targeted approach.
- History of Quality Metrics and the Timelines
- Summary of Findings from the ISPE Pilot Program Wave 1
- Wave 2 Quality Metrics Pilot Overview
- FDA Draft Guidance and ISPE Key Messages
- Upcoming Activities