Our stability commitment for a prescription digestive aid capsule requires that we alternate bottle sizes each year on stability. This is a mature product, so it has settled into a routine cycle between our 100ct and 500ct bottles—both the same plastic, and although the 500ct bottle is larger the headspaces are very similar. Last year we placed a batch of 500ct bottles on stability and a batch of 100ct bottles the previous year, so this year we are required to place 100ct bottles on stability.
I would use Option 3 because it represents what has been commercialized that calendar year. Packaging the smaller size for stability does meet the commitment but does not represent product in the market. Pulling the 100’s from inventory is an option to cover that packaging size, but the a lot representative of the current year would still be needed (option 3).
I would also use Option 3. Both the WHO Annex 10 and Eudralex say:
at least one batch per year of product manufactured in every strength and every primary packaging
type, if relevant, should be included in the stability programme (unless none is produced during that year).
Based on that I do not see a problem with not placing 100st packaging if it is not produced. Placing a batch of 500ct bottles on stability for 2023 is more representative.
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