Planning a Supplement Stability Study Before Setting Shelf Life
The short answer
Stability work should represent the proposed formula, pack and manufacturing process. Define critical attributes, time points and storage conditions before starting; do not use a marketing shelf-life date without suitable data.
Three actions to take
- Freeze the product specification before the study.
- Test the product in the proposed final pack.
- Review trends rather than isolated results.
Start with the real scope
Stability work should represent the proposed formula, pack and manufacturing process. Define critical attributes, time points and storage conditions before starting; do not use a marketing shelf-life date without suitable data.
- Freeze the product specification before the study.
- Test the product in the proposed final pack.
Review the points that change the decision
How to select batches, packaging, tests and time points so stability work supports the shelf-life decision. Record assumptions clearly and separate confirmed data from items that need checking against the official source or actual operation.
- Test the product in the proposed final pack.
- Review trends rather than isolated results.
Turn the review into a usable output
Finish with an owner, version, date and follow-up indicator. This keeps the file useful after delivery and allows it to change with the activity, product or system.
- Freeze the product specification before the study.
- Review trends rather than isolated results.
Need to apply this to your facility?
Share the activity, city and current stage, and we can help define an appropriate work scope.
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