In a stability bill-of-material (BOM), you document the components, substances, or ingredients that make up the material or product to be tested, from a stability or shelf-life perspective. In a stability study for a self-produced drug, for example, the laboratory is usually more interested in the proportion of active ingredients and chemical composition of the compound, rather than the material BOM associated the process order or production order. The stability BOM is used for documentation purposes only. In a BOM, you can also describe the compound or product using text components, which can be especially important for newly developed products.

This procedure describes how you can assign a stability bill-of-material (BOM) to a stability study and later edit the BOM, if necessary. You assign and process a BOM using corresponding follow-up functions in the action box. When you assign a BOM to a stability study, the action is documented as a task in the quality notification.

When you assign a BOM, you must specify an alternative bill-of-material from a bill-of-material group. This is necessary because the substance or product to be tested may have different bills-of-material (alternatives) for different production methods.

2. On the initial screen, enter the key of the stability study you want to process and then choose Enter.

The screen for changing the stability study data appears.

3. In the action box on the right side of the screen, choose the follow-up function Assign Bill-of- Material.

4. If necessary, change any of the proposed values.
5. Enter a value for the Alternative field. If necessary, use the possible entries help to select a value.
6. If you want to assign the bill-of-material with reference to a change number, enter this number in the Change Number field of the Validity group.
7. If you specify a change number, change the Valid From date if necessary.
8. Choose Assign Bill-of-Material to assign the bill-of-material to the study.

The stability BOM is assigned to the stability study.