Final answer:
The duration for which quality control should be assayed when establishing quality control limits varies based on the specific test or process being evaluated. There is no universally fixed time period and it depends on factors such as the nature of the product, desired quality level, and regulatory requirements. Examples include disinfectant manufacturers performing use-dilution tests and bioanalysis studies assessing precision and accuracy through validation runs.
Step-by-step explanation:
When establishing quality control limits, the duration for which quality control should be assayed varies depending on the specific test or process being evaluated. There is no fixed time period that applies universally. The duration is determined based on factors such as the nature of the product, the desired level of quality, and regulatory requirements.
For example, in the case of disinfectant manufacturers validating the efficacy claims for their products, the Association of Official Agricultural Chemists International (AOAC) requires a minimum of 59 out of 60 replicates to show no growth in a test. These manufacturers typically perform use-dilution tests, which may involve multiple batches and different testing days to ensure repeatability.
In another example, in bioanalysis studies, the duration may involve 3-5 validation runs to assess intra and interday precision and accuracy. Additional factors, such as the effect of dilution on precision and accuracy, extraction recovery assessment, and calibration curve quantification, may also affect the duration.
Ultimately, the duration for assay in establishing quality control limits is specific to the context and requirements of the particular test or process being evaluated.