Sterility test method validations can be as difficult as they are important, so understanding practical approaches, especially for products where pharmacopoeial methods cannot be readily applied, can be extremely beneficial.
Topics touched upon include:
- The difficulties associated with sterility test method validation in general
- Practical approaches for products where pharmacopoeial methods cannot be readily applied
- Examples: Mercurial compounds, antibiotics, turbid samples, medical devices, oily samples
- Some supporting aspects for sterility test method validation
- Essential validation documentation
- Guidance on training requirements
