Why Should You Attend:
System suitability testing (SST) is required by USP and FDA to check and ensure ongoing performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation. Also, the USP chapter < 1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. So there are many questions. This webinar will give participants a good understanding of FDA and USP requirements for system suitability testing.
Areas Covered in the Webinar:
FDA and international requirements for system suitability testing
Examples of FDA warning letters and how to avoid them
The role of SST for analytical quality assurance
SST in comparison with equipment qualification and quality control sample analysis
Most critical parameters for SST in EP and USP
Contents of the updated USP chapter < 621>
Recommendations for implementing the updated < 621>
Developing an SOP for system testing
Criteria for SST timing within a sequence of sample runs
Using software for automated system suitability control
The role of SST for method changes according to the updated chapter < 621>
Case studies with practical advice for test parameters and limits
Documenting SST test runs
System suitability testing (SST) is required by USP and FDA to check and ensure ongoing performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation. Also, the USP chapter < 1058> makes a statement that SST can substitute an instrument's performance qualification, but not further guidelines are given. So there are many questions. This webinar will give participants a good understanding of FDA and USP requirements for system suitability testing.
Areas Covered in the Webinar:
FDA and international requirements for system suitability testing
Examples of FDA warning letters and how to avoid them
The role of SST for analytical quality assurance
SST in comparison with equipment qualification and quality control sample analysis
Most critical parameters for SST in EP and USP
Contents of the updated USP chapter < 621>
Recommendations for implementing the updated < 621>
Developing an SOP for system testing
Criteria for SST timing within a sequence of sample runs
Using software for automated system suitability control
The role of SST for method changes according to the updated chapter < 621>
Case studies with practical advice for test parameters and limits
Documenting SST test runs
