Investigating Microbiology Out of Specification Results: Different than Chemistry
Anthony Grilli, MS, Laboratory Director CEO, FOCUS Laboratories
Anthony enlightened the group about the unique requirements of microbiological testing. There are marked differences in equipment, procedures, and test methods. Is there a direct connection between your Stability Group and the microbiology lab? You are important stakeholders to each other.
- Discrete particles
- Will Die or Will Grow or Might Mutate
- Hazard is less clear
- Detectable with technology – but which?
Result: Manual methods and therefore manual documentation that are technique sensitive but may involve several people over time where an OOS may not be known for weeks.