Medical Devices

Stability Program Management and Data Analysis

The stability program may be your most challenging analytical activity. The high volume of data (related to different samples of different ages stored under different conditions) can be difficult to manage and communicate. Very often, critical facts drop through the cracks and come back to haunt you during regulatory filings and inspections. On the other hand, good news is also lost that would benefit product placement and future stability efforts. We've helped clients navigate their stability data in a variety of ways, including:

  • Development, oversight, and review of protocols and assessments related to the stability testing required for meeting guidelines
    • Forced degradation and photostability
    • Long-term and accelerated stability
    • In-use stability
  • Statistical trending of stability data and setting of retest dates
  • Determination of stability indicating assays, and identification of assays that should not be used on stability
  • Tracking of purity and assay on stability, as well as identifying any impurities that may require future characterization