Calyx RIM for Registrations

Add an Active Ingredient Manufacturing Process Function Manufacturer

Using the Global Project Planning (GPP) wizard, you can add an active ingredient manufacturing process function manufacturer to the PDS.

Table 1. Rules Determining the PDS Details Available for Selection
PDS detail Rules for available selections
Active Ingredients All approved active ingredients common to the PDS previously selected in the project.
Functions All manufacturing functions established by your data administrator in Data Administration > Product Detail Set Maintenance > Manufacturer Function Values.
Manufacturer
  • Manufacturers with an active association with each of the selected active ingredients in Data Administration > Product Detail Set Maintenance > Manufacturer Values.
  • Manufacturers that do not already exist as a pending or approved manufacturer for any of the selected active ingredients.
Note: This procedure is a continuation of the Update Product Details Sets project in the GPP wizard. The procedure presented in Creating an Update Product Detail Set Project must be initiated first, followed by initiating Adding a Manufacturer PDS Project.
To add an active ingredient manufacturing process function manufacturer:
  1. On the Select Flow page of the GPP wizard, select Add Active Ingredient Manufacturing Process Function Manufacturer.
  2. Click Next.
    The first Add Active Ingredient Manufacturing Process Function Manufacturer page opens.
  3. Do the following:
    1. Select one or more active ingredients.
    2. Select one or more functions.
  4. Click Next.
    The second Add Active Ingredient Manufacturing Process Function Manufacturer page opens, listing all PDSs with approved manufacturing process functions for approved active ingredient components that also meet the criteria you selected in step 3.
  5. Select one or more PDS from the list.
  6. Click Next.
    The third Add Active Ingredient Manufacturing Process Function Manufacturer page opens.
  7. Select a manufacturer to apply to all of the PDS selected in step 5.
  8. Click Next.
    The manufacturer is added to the PDS and the Perform Another PDS Action page opens.
  9. On the Perform Another PDS Action page, do one of the following:
    • Click Yes to perform another PDS action.
    • Click No to proceed to the Summary page of the GPP wizard.
  10. Click Next.
    One of the following occurs:
    • If you selected Yes in step 9, you return to the Select Action page in the GPP wizard.
    • If you selected No in step 9, the Summary page opens. Proceed to step 11.
  11. On the Summary page, do one of the following.
    • Select the project link on the Summary page to review the new project you created.
    • Click Finish to return to the view from which you invoked the GPP wizard
    In the PDS tree, the added manufacturer appears as a child node of the manufacturing process function for the active ingredient. The status of the added manufacturer is Pending Add and is displayed in parentheses after the name of the manufacturer.