Why is the Quality Metrics Initiative so important? What are the latest developments? How can I participate and make an impact in the pharmaceutical industry?
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. Learn more about this initiative and how it is impacting the pharmaceutical industry.
ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever since it was brought to the forefront of industry thinking in the Food and Drug Administration Safety and Innovation Act (FDASIA).
What are Quality Metrics?
Following the passage of the 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 to assess processes and their risks.
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 Study Underway
A Wave 2 of the pilot has commenced, which will enhance understanding of relationships revealed in Wave 1. Recruiting for Wave 2 is currently underway and provides participants experience in preparing for the logistics and efforts associated with gathering of product-based data, including the FDA proposed metrics set.
More information on the on the ISPE Quality Metrics Pilot Wave 2 and the benefits for participating companies.