Ennov InSight Registrations 7.1

Update a Product Detail Set Project

Global Project Planning (GPP) enables you to update approved product detail set (PDS) details for a PDS related to package set registration applications.

With GPP, you can perform the following update actions on approved PDS details:

  • Add a substance
  • Add indications and intended use details
  • Add manufacturer details to certain approved PDS details
  • Add a manufacturing process
  • Add a manufacturing process step function
  • Add a material
  • Add package sets to a PDS
  • Add component packaging details to a package set
  • Add shelf life details to package sets
  • Add species details for PDS under veterinary product families
  • Add species indications for veterinary products
  • Modify active ingredient details
  • Modify a substance
  • Modify a material
  • Modify component characteristics, such as shape and color
  • Modify manufacturing process step details
  • Modify manufacturing process step function details
  • Modify package set details (package set level only)
  • Modify component packaging details for a package set
  • Modify packaging details for a package set
  • Modify shelf life details in the package sets
  • Modify manufacturing process
  • Withdraw component packaging for package set
  • Withdraw a material
  • Withdraw a manufacturer from a variety of approved PDF details
  • Withdraw a manufacturing process
  • Withdraw a substance
  • Replace a flu strain active ingredient for a flu vaccine product
  • Replace all instances of a manufacturer detail in selected PDS
  • Replace every occurrence of an approved function with a new function
  • Replace all instances of a material used in selected PDS

Using the GPP wizard, you create a project and define criteria to identify the PDS for which you want to update approved PDS details. When updating approved PDS details with the GPP wizard, a corresponding event is created and associated with the PDS and the product related to the PDS. One event is created for each application associated with the PDSs you select to update in the GPP wizard.

The GPP wizard offers two options to search for PDS to act upon. You can search by product and country or search by using an Assemblies Where Document Used query. The second method is available only to users that have the RDA module.

In the GPP wizard, to search for PDSs to update, you can select any of the following search criteria options:

  • Active Ingredient
  • Assemblies Used Query (You can select this option only if you have the RDA module.)
  • PDS Code/PDS Name
  • Product and Country
  • Substance
  • Trade Name

To update PDSs with the GPP wizard, you must have a PDM license with at least WRITE privileges, as well as WRITE privileges to the PDS entity.