Ennov InSight Registrations 7.1

Components

Components are the parts that build the final product. A product may have one or multiple components.

Products can be tracked at a component level of detail.

For example, an ibuprofen tablet has one component, the tablet itself, or a product may have multiple components, like a powder and a diluent to be mixed. Furthermore, components may or may not contain active ingredients and reference active ingredients. For example, a tri-phasal birth control product may have an inert component with no active ingredients and reference active ingredients.
Note: While Ennov InSight does not require you to define component detail for a product, it is considered best practice to define at least one component for a product.
You must have one of the following modules to perform component activities:
  • Product Detail Management
  • Registration Planning and Tracking

Active Ingredients for Components

The active ingredients for a product are tracked at the component level, including the strength measure of the active ingredient in a component. When you define active ingredients for the components of a product, you are limited to the active ingredients that were defined at the product family level.

Reference Active Ingredients for Component Active Ingredients

The reference active ingredients for a product are tracked at the component level, including the strength measure of the reference active ingredient in a component. When you define reference active ingredient for a component active ingredient, you are not limited to the active ingredients that were defined at the product family level. All Substances from Data Administration are available for selection. You must have at least one active ingredient associated with a component to have an ability to associate a reference active ingredient.