Ennov InSight Registrations 7.1

GPP Selections to Update PDS Details

You have several options to update the different types of PDS details in the GPP.
Note: These tables do not include labels, countries, and labeled indication because the GPP does not update these PDS details.

GPP Detail to Update: Active Ingredient (Component)

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add a manufacturer to an active ingredient Add Manufacturer Add Active Ingredient Manufacturer <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturer/<manufacturer>
Add a manufacturer to an active ingredient manufacturing process function Add Manufacturer Add Active Ingredient Manufacturing Process Function Manufacturer <PDS>/<component>/Active Ingredients/<active ingredient/Manufacturing Processes>/<manufacturing process>/<function>/<manufacturer>
Add a manufacturing process Add Manufacturing Process (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/step
Add a manufacturing process step function Add Manufacturing Process Step Function (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/step
Add a material for an active ingredient manufacturing process step Add Material (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes>/<manufacturing process>/<step>/<material>
Modify a Material Modify Material (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes>/<manufacturing process>/<step>/<material>
Modify an active ingredient Modify Active Ingredient (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>
Modify a manufacturing process Modify Manufacturing Process (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>
Modify a manufacturing process step Modify Manufacturing Process Step (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/<step>
Modify a manufacturing process step function Modify Manufacturing Process Step Function (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/<step>/<function>
Withdraw a manufacturing process Withdraw Manufacturing Process (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient/Manufacturing Processes>/<manufacturing process>
Replace an approved flu strain with a new flu strain Replace Flu Strain (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>Flu Strain<flu strain>

PDS Detail to Update: Substance (Component)

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add a substance Add Substance (not applicable) <PDS>/<component>/Substances/<substance>
Add a substance manufacturer Add Manufacturer Add Substance Manufacturer <PDS>/<component>/Substances/<substance>/Manufacturer/<manufacturer>
Add a manufacturer to a substance manufacturing process function Add Manufacturer Add Substance Manufacturing Process Function Manufacturer <PDS>/<component>/Substances/<substance/Manufacturing Processes/<manufacturing process>/<function>/<manufacturer>
Add a manufacturing process Add Manufacturing Process (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>
Add a manufacturing process step function Add Manufacturing Process Step Function (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/step
Add a material for a substance manufacturing process step Add Material (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes>/<manufacturing process>/<step>/<material>
Modify a material Modify Material (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes>/<manufacturing process>/<step>/<material>
Modify a manufacturing process Modify Manufacturing Process (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>
Modify a manufacturing process step Modify Manufacturing Process Step (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>/<step>
Modify a manufacturing process step function Modify Manufacturing Process Step Function (not applicable) <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>/<step>/<function>
Modify a substance Modify Substance (not applicable) <PDS>/<component>/Substances/<substance>
Withdraw a manufacturing process Withdraw Manufacturing Process (not applicable) <PDS>/<component>/Substances/<substance/Manufacturing Processes>/<manufacturing process>
Withdraw a substance Withdraw Substance (not applicable) <PDS>/<component>/Substances/<substance>

PDS Detail to Update: Manufacturing (Component)

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add a manufacturer to a component function Add Manufacturer Add Component Function Manufacturer <PDS>/<component>/ Manufacturing/Function/<function><manufacturer>
Add a manufacturer to a component manufacturing process function Add Manufacturer Add Component Manufacturing Process Function Manufacturer <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<function><manufacturer>
Add a manufacturing process Add Manufacturing Process (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>
Add a manufacturing process step function Add Manufacturing Process Step Function (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/step
Add a material for a component manufacturing process step Add Material (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
Modify a material Modify Material (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
Modify a manufacturing process Modify Manufacturing Process (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>
Modify a manufacturing process step Modify Manufacturing Process Step (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>
Modify a manufacturing process step function Modify Manufacturing Process Step Function (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<function>
Withdraw a manufacturing process Withdraw Manufacturing Process (not applicable) <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>

PDS Detail to Update: Characteristics (Component)

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Modify component characteristics Modify Component Characteristics (not applicable) <PDS>/<component>/Characteristics/Characteristics

PDS Detail to Update: Indications Intended Use

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add indications/intended use Add Indications/Intended Use (not applicable) <PDS>/Indications/Intended Use/<indication/intended use>

PDS Detail to Update: Manufacturing

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add a manufacturer to a PDS manufacturing function Add Manufacturer Add PDS Function Manufacturer <PDS>/Manufacturing/Function/<function><manufacturer>
Add a manufacturer to a PDS manufacturing process function Add Manufacturer Add a PDS Manufacturing Process Function Manufacturer <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>/<function>/<manufacturer>
Add a manufacturing process Add Manufacturing Process (not applicable) <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>
Add a manufacturing process step function Add Manufacturing Process Step Function (not applicable) <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/step
Add a material for a manufacturing process step Add Material (not applicable) <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
Modify a manufacturing process Modify Manufacturing Process (not applicable) <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>
Modify a manufacturing process step Modify Manufacturing Process Step (not applicable) <PDS>/Manufacturing Processes/<manufacturing process>/<step>
Modify a manufacturing process step function Modify Manufacturing Process Step Function (not applicable) <PDS>/Manufacturing Processes/<manufacturing process>/<step>/<function>
Withdraw a manufacturing process Withdraw Manufacturing Process (not applicable) <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>

PDS Detail to Update: Package Set

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add a manufacturer for packaging in a package set Add Manufacturer Add Package Set Packaging Manufacturer <PDS>/Package Set/<package set>/Packaging/<package>/<manufacturer>
Add a manufacturer for a function in a package set Add Manufacturer Add Package Set Function Manufacturer <PDS>/Package Set/<package set>/Function/<function>/<manufacturer>
Add a manufacturer for component packaging in a package set Add Manufacturer Add Package Set Component Packaging Manufacturer <PDS>/Package Set/<package set><component>/Packaging/<package><manufacturer>
Add packaging to a component in package set Add Component Packaging to Package Set (not applicable) <PDS>/Package Set/<package set><component>/Packaging/<package>
Modify packaging for a component in a package set Modify Component Packaging for Package Set (not applicable) <PDS>/Package Set/<package set><component>/Packaging/<package>
Withdraw packaging for a component in a package set Withdraw Component Packaging for Package Set (not applicable) <PDS>/Package Set/<package set><component>/Packaging/<package>
Add a package set Add package set (not applicable) <PDS>/Package Set/<package set>
Modify a package set Modify package set (not applicable) <PDS>/Package Set/<package set>
Modify packaging for a package set Modify Packaging for Package Set (not applicable) <PDS>/Package Set/<package set>/Packaging/<packaging>
Add shelf life Add Shelf Life (not applicable) One of these:
  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s)/<shelf life>
  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s) After Opening<shelf life>
  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s) After Reconstitution<shelf life>
Modify shelf life Modify Shelf Life (not applicable)

One of these:

  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s)/<shelf life>
  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s) After Opening<shelf life>
  • <PDS>/Package Set/<package set>Shelf Life(s)/Storage Condition(s) After Reconstitution<shelf life>

PDS Detail to Update: Species Veterinary Products

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Add species Add Species (not applicable) <PDS>/Species<species>
Add species indications Add Species Indications (not applicable) <PDS>/Species/<species>/Indications/<species indication>

PDS Detail to Update: Manufacturer

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Replace every occurrence of an approved manufacturer with a new manufacturer Replace Manufacturer (not applicable) Any path to a manufacturer. The paths to manufacturers are those shown in the other rows of this table plus the following:
  • <PDS>/<component>/Active Ingredients/<active ingredient/Manufacturing Processes>/<manufacturing process>/<step>/<material>/<manufacturer>
  • <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step><material>/<manufacturer>
  • <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>/<manufacturer>
Withdraw an approved manufacturer from the selected approved manufacturer parent type Withdraw Manufacturer (not applicable)
Important: Options available in the Manufacturer Parent Type multi-select field:
  • Active Ingredient
  • Active Ingredient Manufacturing Process Function
  • Active Ingredient Manufacturing Process Step Function
  • Active Ingredient Manufacturing Process Step Material
  • Component Function
  • Component Manufacturing Process Function
  • Component Manufacturing Process Step Function
  • Component Manufacturing Process Step Material
  • Package Set Component Packaging
  • Package Set Function
  • Package Set Packaging
  • Product Detail Set Function
  • Product Detail Set Manufacturing Process Function
  • Product Detail Set Manufacturing Process Step Function
  • Product Detail Set Manufacturing Process Step Material
  • Substance
  • Substance Manufacturing Process Function
  • Substance Manufacturing Process Step Function
  • Substance Manufacturing Process Step Material
Any path to a manufacturer. The paths to manufacturers are those shown in the other rows of this table.

PDS Detail to Update: Material

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Withdraw every occurrence of a material Withdraw Material (not applicable) Any path to a material added to a processing step:
  • <PDS>/<component>/Active Ingredients/<active ingredient/Manufacturing Processes>/<manufacturing process>/<step>/<material>
  • <PDS>/component/<Substances>/substance/Manufacturing/Manufacturing Processes/<manufacturing process>/<step><material>
  • <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
  • <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
Replace every occurrence of an approved material with a new material Replace Material (not applicable) Any path to a material added to a processing step:
  • <PDS>/<component>/Active Ingredients/<active ingredient/Manufacturing Processes>/<manufacturing process>/<step>/<material>
  • <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>/<step>/<function>
  • <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>
  • <PDS>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<material>

PDS Detail to Update: Manufacturing Process Step Function

Update Task Select Action on the Select Action Page Select Type of Manufacturer on the Select Flow Page Path to Updated Details
Replace every occurrence of an approved function with a new function Replace Manufacturing Process Step Function (not applicable) Any path to a manufacturing process step function:
  • <PDS>/<component>/Active Ingredients/<active ingredient>/Manufacturing Processes/<manufacturing process>/<step>/<function>
  • <PDS>/<component>/Substances/<substance>/Manufacturing Processes/<manufacturing process>/<step>/<function>
  • <PDS>/<component>/Manufacturing/Manufacturing Processes/<manufacturing process>/<step>/<function>
  • <PDS>/Manufacturing Processes/<manufacturing process>/<step>/<function>