Not all methods need to be validated. Compendia methods, e.g., as published in the USP-NF, are WIDELY accepted as needing only minimal documentation of fitness for use for a given site. An already-validated method may only require a few experiments to verify it for use. Validation of methods for characterization of compounds may not be practical. There are a number of less-demanding approaches to ensuring a method produces valid results and otherwise exhibits scientific integrity.

Method transfer is the DOCUMENTED evidence that a previously validated method has been verified for use at a location other than where it was originally validated.

There are several means of doing so:

• Comparative testing – The originating and receiving laboratories analyze different SETS of APPROPRIATELY equivalent samples. Results are compared to pre-defined transfer acceptance criteria.
• Co-validation – The receiving laboratory participates in the initial method validation activities. This can be in support of ESTABLISHING method ruggedness through inter-laboratory testing, for instance.
• Method validation or revalidation – Complete or partial (re-)validation is performed on the method by the receiving laboratory.
• Transfer waiver – No experimental confirmation is needed for the transfer of the method. The rationale for this decision is formally documented to approve the method for use at the receiving laboratory. Reasoning may be based on parallel methods already in use, similarity of systems and environment, or prior experience of receiving lab personnel with the method being transferred.

Method verification is the documentation that a compendia or otherwise standard method is suitable for use at a given site. It involves confirmation that the scope of use is the same as the published scope and those parameters are not changed outside of tolerances, and is supported by experimental data assessing critical method performance characteristics.

Method qualification is similar to method validation, but it does not require the method under test to be in a finalized form. Method qualification can, therefore, serve to inform method development activities in the final stages of preparing the method for actual validation. They may, for instance, be used to assign validation acceptance criteria. Data from a method qualification might also be used to support method robustness in the Validation Summary Report.

Not all methods need to be validated. Compendia methods, e.g., as published in the USP-NF, are widely accepted as needing only minimal documentation of fitness for use for a given site. An already-validated method may only require a few experiments to verify it for use. Validation of methods for characterization of compounds may not be practical. There are a number of less-demanding approaches to ensuring a method produces valid results and otherwise exhibits scientific integrity.

Method transfer is the documented evidence that a previously validated method has been verified for use at a location other than where it was originally validated.

There are several means of doing so:

Method verification is the documentation that a compendia or otherwise standard method is suitable for use at a given site. It involves confirmation that the scope of use is the same as the published scope and those parameters are not changed outside of tolerances, and is supported by experimental data assessing critical method performance characteristics.

Method qualification is similar to method validation, but it does not require the method under test to be in a finalized form. Method qualification can, therefore, serve to inform method development activities in the final stages of preparing the method for actual validation. They may, for instance, be used to assign validation acceptance criteria. Data from a method qualification might also be used to support method robustness in the Validation Summary Report.