S.No |
|
1 |
Changes to the product that could affect method performance (e.g., formulation excipients, product concentration) |
2 |
Changes in critical assay reagents that cannot meet prior specifications (e.g., gel or blot materials, enzymes) |
3 |
Changes in instrumentation that cannot perform equivalent procedures (e.g., hydrolysis systems) |
4 |
Changes in the procedure to improve robustness of the method (e.g., new qualification procedures for critical reagents, re-optimized sample preparation steps) |
5 |
Changes in the product specifications that go beyond the capabilities of the test method (e.g., specification on quantifying impurities drops from 0.5% to 0.1%; assay limit of quantitation is 0.25%) |
|