Table of contents
Stability templates
This table contains the list of shelf-life extension strategies. One stability template must be defined for each stability extension strategy used in the project. Stability with a fixed shelf-life should be seen as a particular case of strategy with no extension, i.e. containing only the initial milestone (0 month), e.g., fixed 12 months of shelf-life.
The same stability template can be used for multiple stability plans (see below) as long as they all follow the same series of milestones and shelf-life extensions.
Stability milestones
List of shelf-life extension milestones for each stability study template. For one given stability template, each row represents a relative milestone (time from the stability date), and the value of the expected shelf-life at that milestone.
The expiry date of a lot, at the time of its labelling, is defined as follows :
Expiry date = manufacturing date + shelf-life
Note that the manufacturing date in this formula is either the start or end date of manufacturing (depending on whether “Expiry for end” is unchecked or not).
The milestone defines which shelf-life to apply in the formula above.
Milestone 0 = Stability date + analysis duration + release duration + approval duration
Example
Suppose a stability date of Jan-21, a production lot manufactured on May-21 and suppose a stability template with the following milestones and shelf-lives :
|
Milestone |
Shelf-life |
|---|---|
|
0 |
12 |
|
3 |
18 |
|
6 |
24 |
|
9 |
30 |
|
12 |
36 |
Moreover, suppose an analysis duration of one month, a release duration of one month and an approval duration of 2 months. This means that the milestone 0 will begin 4 months after the stability date, therefore in May-21.
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For a labeling of kits using products of the manufactured lot and occurring between May-21 and Aug-21, the expiry date will be May-22 as only the first milestone (0) will be available (approved) during that period, i.e., 12 months of shelf-life, starting from the manufacturing date (May-21).
-
For a labeling occurring between Aug-21 and Nov-21, the expiry date will be Nov-22 as the second milestone (3), i.e. the first extension, will be released and approved, i.e., 18 months of shelf-life, starting from the manufacturing date (May-21).
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For a labeling occurring between Nov-21 and Feb-22, the expiry date will be May-23 as the third milestone (6), i.e. the second extension, will be released and approved, i.e., 24 months of shelf-life, starting from the manufacturing date (May-21).
-
And so on…
Tip
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Only one milestone is defined at 0 month for fixed shelf-life templates.
Stability plans
This table allows to define stability plans that will determine the expiry of products manufactured at production resources. A stability plan must be defined to associate a stability template and a stability starting date to a set of production resources and products that are subject to the same stability program.
The stability plan is used to determine the expiry of the related products and the subsequent products in the production chain. It is typically defined at the DP level and determines the expiry of underlying IMP lots. If stability plans are defined both at DS and DP levels, the stability plan of the DS product will play a role in the usage of the DS product as input for the DP production but will be overridden by the stability plan of the DP level for the usage of the underlying DP and IMP products.
If no stability plan is assigned to a production line, the system will consider that either the expiry is defined by a previous production stage or there is an unlimited shelf-life. If a subset of studies or regions is specified, then the stability plan is considered only when satisfying demands for those studies or regions.
One stability plan (one row in the table) can be associated to multiple products and/or multiple production resources as long as they use the same extension template, the same starting date, the same analysis, release and approval durations and apply to the same set of studies and regions.
A stability plan must be defined and assigned to the production resource, even for a fixed shelf-life (no extension). Moreover, in the case of fixed shelf-life, the stability date should be set before the planning horizon. Also, analysis, release and approval durations should be set to 0.
Allocation constraints
Tip
-
Allocation constraints can be excluded from the optimization without having to delete all related data by using the Use checkbox
.
Allocation constraints are used to constrain how lots manufactured in a given production resource can
be allocated to studies and/or regions. The constraint defines the set of studies and regions that can be supplied by a set of production resources. This is typically used to inform the system that a production
resource may not have been registered for some new studies and could therefore not be allocated to
those studies.
When no constraint has been entered for a given production resource, it is assumed it can be allocated to all studies and all regions.