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In some regions, an advisory best before, mandatory use by or freshness date is required on packaged perishable foods.

Shelf life is the recommended maximum time for which products or fresh (harvested) produce can be stored, during which the defined quality of a specified proportion of the goods remains acceptable under expected (or specified) conditions of distribution, storage and display.

A summary of the notable updates is provided in Attachment 1 to this .

The effective date (with the exception of the Intermediate Storage Condition) of this guidance document is April 1, 2004.

This article examines the decisions to be made regarding the design of a stability strategy during development and some alternative approaches, compared to those traditionally followed, are proposed as being more scientifically rigorous.

Following these approaches would lead to better product understanding and robustness as well as to a reduction in the number of scientifically redundant stability studies.

This and other Guidance documents are available on the Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate/ Marketed Health Products Directorate Website (s).A draft version of this document of the same title was released for Stakeholder consultation in 1997.This finalized version has been to updated include revisions as a result of the maintenance of the parent guidance, additional clarification as a result of comments that have been received (where appropriate), as well as to promote consistency with other Health Canada guidance documents.The integrity of an aqueous trace metals standard is dependent upon: is the amount of time that a properly packaged and stored standard will last without undergoing chemical or physical changes, remaining within the specified uncertainty.A change greater than that uncertainty (±0.5% relative for our standards) means the standard has gone over (passed) its shelf life.

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