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Product

Table of contents

 

Tip

  • Product groups and recipes can be excluded from the optimization without having to delete all related data by using the Use checkbox :ballot_box_with_check: .

Stages

This table contains production stages to be considered for a scenario.

 

The order of the rows is very important and reflects the logical order of the stages along the production chain (e.g., 1-DS, 2-DP, 3-IMP).

Some stages may be skipped in the production chain of some products.

Examples of codes and labels of stages :

  • DS : Drug substance

  • DP : Drug product

  • DV : Device

  • IMP : Investigational Medicinal Product

 

In all tables, codes should be unique, short and self-explanatory because they are used for referencing in other tables and they appear in the report.

Codings

This table contains rules to apply for generating codes for the lots. A lot code is formed by a prefix followed by a fixed number of digits and starting from an initial value.

Example : if the prefix is 'XYZ', the number of digit is 6 and the initial value is 100, codes generated will be taken from the following sequence: XYZ000100, XYZ000101, XYZ000102, ...

Lots associated to the same coding rule will receive codes from the sequence in the chronological order of manufacturing date. This applies only for new lots generated in the planning horizon. Existing or planned lots (initial, imported or frozen lots) will keep their code as defined in the Initial, Imported and Frozen Productions table.

Product groups

This table allows defining product groups. A product group links multiple products from the same stage (e.g., active and placebo kits) and allows defining synchronization constraints between lots produced for the linked products. For example, if product P1 and product P2 belong to a same group, and production resource R can produce both P1 and P2, then it is possible to force production resource R to produce the same number of lots for product P1 and P2.

Lots produced on a same production resource for the grouped products can be synchronized in different ways:

  • Synchronization can apply on the manufacturing dates, on the availability dates or the release dates. For example, if production resource R produces lot L1 for product P1 and lot L2 for product P2, and assuming lots are synchronized on the release dates, then the date of release of lot L1 will be the same as the one of lot L2.

  • Lots can also be synchronized in size according to the ratio defined in the Products table.

  • Finally, lots can be synchronized in the way they are allocated to demands. This is applicable only per study and region for which demands are grouped. That is to say, demands occurring at the same date and with the same minimum remaining shelf-life for each product from the group.

    • For example, if demands D1 and D2 are grouped for a given study and region, and assuming synchronization applies on demand, if lot L1 is grouped with lot L2 and L1 is allocated to D1 then L2 must be allocated to D2. Synchronization on demands is typically used to enforce the same expiry (the most constraining one) on the grouped lots.

Products

List of all products (from all production stages) related to a given scenario. Some data need to be entered (code, unit, stage, grade) while other are optional (form, state, purity).

 

Tip

  • The table can be filtered by stage.

Recipes

Each row represents the consumption of one product of a previous stage (Product in) to produce one unit of product from a given stage (Product out). There can be multiple input products for one output product. All rows related to one given output product (one Product out code) represent the recipe to produce this output product.

Rate column represents the quantity of input product units consumed to produce one unit of the output product.

  • For example, if 100mg of drug product (i.e., Product out) needs 200mg of drug substance (i.e., Product in) to be made, the rate (Product in/Product out) will be 200/100 = 2.

If there is a loss of input product in the manufacturing of the output product, this loss is entered separately as a percentage of the input product quantity (Input loss column).