Discussion of the verification of compendial methods when introduced in a laboratory. This is patterned after USP and the FDA Stimulus Article
According to the US GMPS; "The suitability of all testing methods shall be verified under actual conditions of use". This is supported by the USP, which states; "Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use." A modified definition of the accepted definition of test method validation "Documented evidence that the test method performs as intended in the using laboratory" supports the concept of method verification.
It is clear that when a test method is moved into any laboratory that has not performed the test before the firm must do something to demonstrate that the test method performs as intended. The transfer could be from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. The firm must demonstrate that the receiving laboratory is capable of performing the test and that the test results accurately reflect the attribute being tested.
The term method verification took on a new meaning when the USP published its stimulus article on the test method lifecycle that proposes Continued Test Method Verification during stage 3 of the test method lifecycle.
This webinar will discuss test method verification and what should be considered for the method verification project.
For more details and registration visit: www.compliancetrainingpanel.com