Documentation of the method should include a detailed written procedure, a method validation report, system suitability criteria, and a plan for the methods implementation. General acceptance criteria for the methods’ intended purpose should also be included. The end user should plan on spending time verifying method performance prior to the method being placed on-line. If the end user has been involved in the overall process of validation, either as an observer, or as a participant (i.e. inter-laboratory collaboration), the method can be placed on- line in a most timely fashion.

At some time during the lifetime of a method, for one reason or another, it may become necessary to revalidate the method. Revalidation can be carried out in a reactive or proactive manner. Reactive revalidation may be performed in response to changes in incoming raw material, manufacturing batch changes, formulation changes, or any other changes (dilutions, sample preparation) in the method. A total revalidation from scratch is usually not called for in these instances, but enough revalidation to address the issues at hand as dictated by the needs and use of the method must be performed. Proactive revalidation may be undertaken to take advantage of new technology, or perhaps to automate a previously complex, labor and/or time consuming manual procedure. In such cases, revalidation may be more comprehensive, depending on the undertaking.