AMV Categories and Prospective Validation/Verification Studies (7)
| AMV Category Description | Risk/Uncertainty Level (1 = Low, 5 = High) | Prospective Studies | ||
|---|---|---|---|---|
| AMV Category No. | Analytical Method | Product/Process Sample | ||
| A | New | New | 4–5 | Full Validation |
| B | New | Old (Validated) | 3–4a | Full Validation Plus AMC Studies |
| C | APT No major change(s)b | New | 1–2 | Formal Verification |
| D | Compendial | New | 1–2 | Formal Verification [USP <1226>] |
Note: AMC, analytical method comparability; AMV, analytical method validation; APT, analytical platform technology.
↵a Category B applies when a validated analytical method is replaced by a new method. If a new analytical method (forced method replacement) is needed due to supply reasons, the risk level can be generally considered higher because no other option may exist. Unforced test method replacements can be considered to be a lower risk level, as more time may be available to optimize the method performance.
↵b Some changes to validated APT methods such as a different sample preparation step or the use of a different detection system may not require a full validation as only a part of the validated test system changes, whereas most of the system remains unchanged.