05.24.22 -- FDA Seeks Public Comment On Quality Metrics Reporting Program

The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes.