A shelf-life study is planned around product variability and the evidence needed for a decision. There is no sample count that fits every product.

Write the study question. Define the product and production lots, package format, storage scenario, quality or safety endpoint, and analytical method. Without these, a sample or time-point count cannot guide a decision.

Build the sampling schedule with the laboratory

Set baseline, expected change period and decision point in the study plan; select independent lot/package samples and replicates with the laboratory's rationale. Record lot, time, conditions, method, device and result for each sample.

Archive raw results, deviations, sample preparation and transport conditions together. Have the authorised quality team review the study; a model curve alone is not a safe shelf-life or release criterion.