The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.
In normal circumstances, the requirement for method transfer arises with the transfer of the method from the Method Development environment to the routine Quality Control testing laboratory. Ideally, however, the existence of method transfer any time a method is transferred from one laboratory to another should be in place, as this would also address and include the transfer of the method into more environments, such as a stability testing laboratory, or a contract laboratory or the testing laboratory of a contract manufacturer.
Support for verification of test methods
The US GMPS requires the verification of test methods under actual conditions of use to verify the suitability of all testing methods. The USP seconds this, stating that “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”.
The concept of method verification is also supported by a modified version of the accepted definition of test method validation, which requires documented evidence to ensure “that the test method performs as intended in the using laboratory”.
So, what does this mean for laboratories that have not performed the test before? Such firms must demonstrate something to prove that the test method performs as intended. This has to be done irrespective of whether the transfer is from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. All that is needed for the firm is to demonstrate that the receiving laboratory has the capability to perform the test, and also that the test results are an accurate reflection of the attribute being tested.
A learning session on method transfer and method verification
However, many companies do not understand what should be done for a thorough, successful test method transfer. A webinar from Compliance4All, a highly respected provider of professional trainings for all the areas of regulatory compliance, will explain all the intricacies of method transfer and method verification.
At this webinar, Jerry Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System, will be the speaker. In order to understand the complete nitty-gritty of method transfer and method verification, please register for this valuable webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501282LIVE?Linkedin-SEO
The term method verification acquired a new shape and meaning with the USP’s publication of its stimulus article on the test method lifecycle. This stimulus article proposes Continued Test Method Verification during stage 3 of the test method lifecycle. At this webinar, Jerry will discuss test method verification and what all need to be considered for the method verification project.
This learning, on all areas of method transfer and method verification, will be extremely useful and valuable for Laboratory Directors, Managers, Supervisors and Analysists in any laboratory performing GMP testing.
At this session, Jerry will cover the following areas:
o The requirements for test method verification when a method is transferred from one laboratory to another
o What might be included in the method verification that accompanies a test method transfer?
o The regulatory and compendial expectation for test method verification as a part of the test method lifecycle
o What might be included in continued test method verification?