Ennov InSight Registrations 7.2

Associating a Substance with a PDS

You can associate a Substance with the PDS by choosing among the available types. Two substance types are available for you to choose by default - Excipient and Adjuvant. You can create and use your own types.

To associate substance with a PDS:
  1. In the PDS tree on the Product Detail Set page, expand the tree node for a component, and then right-click the Substance node and choose Add Substance.
    The Add Substance page opens in the right pane.
  2. On the Add Substance page select the substance type you want to add Excipient or Adjuvant from the drop-down
  3. Select the Substance name by clicking the Select button.
    1. Enter the values for the excipient or adjuvant PDS attributes.
    Note: If you set the Use as Active Ingredient for XEVMPD field to Yes and there is no PDS Active Ingredient value, then the data from Substance Detail is added as an Active Ingredient (regardless of the selected Substance Type) in the XEVMPD XML creation via the XEVMPD Submission Wizard. If you set this field to No, then Substance Detail is used as an Excipient or Adjuvant, depending on the selected Substance Type.
  4. Click Save.
  5. After associating substance with a PDS, you can associate a manufacturer with the excipient or adjuvant. See the topic Associating a Manufacturer for more information.

    When associating a substance to a component, you define the role that the substance serves in the delivery of the component.

    For PDS and PDS Template you can add, delete or modify:
    • Manufacturing Process under substance detail
    • Step under manufacturing process
    • Function under step
    • Manufacturer under function
    • Material under step
    • Manufacturer under the material
    • Function under manufacturing process
    • Manufacturer under function