Final answer:
Statistical quality control limits for analytical methods should be established during the validation process, according to guidelines provided by regulatory agencies. This process includes assessing parameters such as selectivity, sensitivity, linearity, precision, and accuracy.
Step-by-step explanation:
The establishment of statistical quality control limits for each analytical method should occur during the validation process. In bioanalytical methods, this validation is typically done according to guidelines provided by regulatory agencies such as the International Council for Harmonisation (ICH) and the European Medicines Agency (EMA). The validation process includes assessing parameters such as selectivity, sensitivity, linearity, precision, and accuracy.