Shelf-life dates of pharmaceutical products are critical and need to comply with several regulations, such as 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals, and stability testing is needed to support the definition of the rules for the calculation of retest date and expiration date.
Within Microsoft Dynamics 365 Finance & Supply Chain Management, it is possible to define the following periods for an item in the Released product details form (Product information management > Products > Released products > Released product details):
Shelf advice period in days: used to automatically calculate the Shelf advice date (that is, Retest date) of a batch (Shelf advice date = Manufacturing date + Shelf advice period in days).
Shelf life period in days: used to automatically calculate the Expiration date of a batch (Expiration date = Manufacturing date + Shelf life period in days).
Best before period in days: used to automatically calculate the Best before date of a batch (Best before date = Expiration date – Best before period in days).
Due to the impact of dates on product quality and patient safety, Life Sciences Supply Chain Management extends the standard capabilities by providing:
The ability to automatically assign the manufacturing date to the material received in inventory based on predefined rules.
Restrictions on shelf-life periods, shelf-life dates, and vendor batch dates to guarantee the accuracy of the calculation.
The capability to calculate shelf-life dates based on advanced rules.
The definition of the Destroy by date for batches and sub-batches to record the date by when the material should be destroyed.