The AMV protocol and report should formally verify that the method is valid (from a quality and product-release perspective) and validated (from a compliance perspective).6,7 The AMV protocol contains a summary of AMD results for the new method, and, for changed methods, historical data (AMV and release data) generated using the current method. It also provides current or expected in-process and product specifications, which determine whether the new method is suitable for comparing product quality attributes to specifications.
INTERMEDIATE PRECISION It is only necessary to evaluate one product batch to determine intermediate precision within the AMV protocol. We are not evaluating production process variability, so controllable factors should be held constant to obtain meaningful results for variable factors (for example, different operators). AMD is the proper time to evaluate several product batches to provide an overall estimate of batch-to-batch precision.