A shelf-life study should represent the product and intended conditions. If formulation, ingredients, process, packaging or distribution changed, first assess whether the existing study still applies.
The protocol should specify product lots, sampling, storage conditions, test methods and measurement points. Link sample identity to production and packaging records.
Define quality indicators separately from microbiological or other safety criteria. Product specialists and the authorized quality owner should decide which criteria apply.
Monitor storage and distribution conditions with time-stamped records. Include instruments, deviations and sample transport conditions in the study file.
Assess results against criteria set in advance; observed spoilage or a single laboratory result does not itself determine a market release decision.
The report should show scope, deviations, results, uncertainty and approver. When product or process changes, assess the impact and document whether further study is needed.
