AMERT

As shown in Figure 11, before extensive validation, the performance of the method is evaluated appropriately. Column durability tests, robustness testing for the chromatographic and sample preparation conditions, analytical method evaluation ring tests (AMERTs), method capability assessments, and pre-validation studies are applied to... 

The AMERT is an important part of the analytical method development process. The AMERT allows to verify whether the draft method performs adequately for its intended purpose and complies with the specific country requirements. The concept of performing an AMERT was introduced by Crowther et al. and has been further discussed by Jimidar and De Smet. Detailed description of the approach is presented in reference 1. 

At the conclusion of development, when methods are locked, it is becoming more common for the analysts to ask the quality unit for input and comment on the proposed method package before final validation. Such a method test drive can avoid problems with the formal transfer taking place later. This process has been termed an analytical method evaluation ring test (AMERT) by Crowther and associates and was presented and described elsewhere. In brief, this process allows the quality unit to make comments and suggestions to their R D colleagues before the final validation of the method. It is also becoming more common for the quality unit to approve method validation protocols. This provides the quality unit with an opportunity to ensure that the method meets the performance expectations to enable routine use in the quality environment. In some cases, covalidation by the R D and Quality Units (discussed below) replaces formal method transfer. Thus, the frequently seen throw the method over the fence syndrome is avoided. 

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