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.

Create a Component

You create a component for a product, and add it to the list of components for that product. Depending on the type of component, you specify information such as the component's physical form, the route of administration, the type of sterilization, and so on.

You must have the appropriate security privileges to create a component. If you have the rights to add a product, you can add a component. Also, you cannot create a component for a product that already has a PDS template or application associated with it.

You can create components for an existing product or when you create a product.

To create a component:

Navigate to the product for which you want to associate a component.
While viewing the Product Attributes page, click the Components tab.
Click Create.
The Create Component page appears.
Select a component type.
The values available in the drop-down list were created by your Ennov InSight system administrator and are mapped to an entity type of pharmaceutical, medical device, pharma-med device combination, flu vaccine, or veterinary.
Enter a name for the component.
You must enter a name, unless in the next step you select a component form when defining the component attributes. In that case, the component name defaults to the selected form, but you can change the name.
Enter the additional component attribute values, as needed.
Do one of the following:

— Save, to save the component.

— Create Another Component, to save this component and create another.

— Save and Add Active Ingredients, to save this component and add active ingredients. This option is available for all except Flu Vaccine and Medical Device component types.

If your component contains at least one active ingredient, you can create a reference active ingredient that is also tracked at the component level of your product.

Component Attributes

The attributes that are available for a component depend on the component type. Key for Component Type:

— FV for the flu vaccine component type

— P for the pharmaceutical component type

— MD for the medical device component type

— PMD for the pharmaceutical-medical device component type

— V for the veterinary component type

— All for all component types


Attribute	Component Type	Description
Active Ingredients	FV	Active ingredients available for selection that are associated with the product family.
Allergenicity Indicator	MD	Specifies whether the device contains allergens and/or materials of concern.
Component Add Comment	All	Comments you want to share with others in a discussion thread. Comments are stamped with the date and time you enter the information, and your user ID.
Component Code	All	The Code for the specific component.
Component Comments	All	The discussion thread that includes all comments entered by users, plus the date and time the comments were entered and the user ID of the person who entered them.
		*Note:* Comments are available on the Modify Components page.

Component Concerned Parties	All	Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Component Description	All	Text that describes the component.
Component Form	FV, P, PMD, V	The physical form in which this component is produced and dispensed. For example: tablet, capsule, powder, or liquid.
Component Keywords	All	Words you can use to search for the component.
Component	MD, PMD	Locations of the device manufacturers (assuming there are no product detail sets).


Manufacturing Location
Component Name	All	Name given to identify the specific component. If this is a single component product, the name would most likely be the same as the product name.
Attribute	Component Type	Description
Component National Drug Code	FV, PMD, V	Universal product identifier for human drugs. There are three segments to the Component National Drug Code: — Labeler code - pertains to the manufacturer — Product code - pertains to the bulk product — Packaging code - pertains to the presentation (e.g: 5pack, 10pack, bottle, blister, etc.) For devices, NDC only applies to medical devices that have a drug component(s).
Component Owner/ RA Responsible	FV, MD, PMD, V	RA person responsible for the component.
Component Route of Administration	FV, P, PMD	How the component is to be administered. The values that appear for this attribute are based on the dosage form you selected. You may select multiple routes of administration. This field may be left blank because the component itself may not administered, rather it is the combination of components that define the administration.
Component Sterilization	MD, PMD	Defines the type of sterilization the device provides.
Component Type	All	Defines the type of component. The component type is based on the entity type to which it is associated: pharmaceutical entity type, medical devices entity type, or a pharmaceutical-medical devices combination.
Device Alternate Material	MD	The alternative material(s) of the device.
Device Material	MD	The material(s) of the device.
Device Nomenclature	MD	The term for the device from the specified nomenclature system.
Device Type	MD	The type of device.
Device Usage	MD	The number of times that the device may be used.
Family Code	All	The code of the product family to which this component is associated.
Family Name	All	The name of the product family to which this component is associated.
Model Number	MD	Specifies the device model or reference number, where applicable, in text.
Attribute	Component Type	Description
Product Name	All	The standard product name recognized internally and across countries.
Product Family Type	All	The product family type to which this component is associated.
Product Name	All	The name of the product to which the component is associated.
Sterility Indicator	MD	Specifies whether the device is supplied as sterile.
Sterilization Requirement Indicator	MD	Specifies whether the device shall be sterilized before use.

Modify a Component

The attributes you can modify for a component depend on the component type. Different attributes are available for pharmaceutical, medical device, pharmaceutical-medical device, and veterinary components.

To modify a component:

Click a link for the component you want to modify.
On the Component Attributes page, click Edit.
The Modify Component Attributes page opens.
Enter your changes to the component attributes.
Save, to save your changes.

Copy a Component

You can copy a component to add additional components to a product. You must have at least Write permission for both Product Family and Products to copy a component.

To copy a component:

Click the link for the component you want to copy.
On the Component Attributes page, click Copy.
After the copy process is complete, you are returned to the Component Attributes page of the source component that you copied.
Click the Product Name link. The Product Attributes page opens. On the Components tab, the new component is listed with Copy <#> of prepended to the name of the source component you copied, where <#> represents the number of times you have copied the source product.
To change the name of the new component as well as other component attributes, click the link of the new component to open the Component Attributes page, and then click the Edit icon.

Note: If source Component had associations with Pharmaceutical Product this associations will not be copied.

The Modify Component Attributes page opens.

View a Component

You can view a component to see all its attributes, and take action on the component.

You can modify, delete, and copy a component. You can also maintain active ingredient information for pharmaceutical, pharmaceutical-medical device, and veterinary type components.

To view a component:

Click a link for the component you want to view. The Component Attribute page opens.
On the Component Attributes page, do any of the following:

— To modify the component attributes, click Edit.

— To delete the component, click Delete. With the appropriate security privileges, you can delete a component if there are no notifications associated with the component, and if there are no PDS templates or applications associated with the product to which the component is associated. — To copy the component, click Copy.

— To create an Entity History query so you can review the component history, click Report.

— To view an active ingredient associated with the component, on the Active Ingredients tab click the link for the active ingredient that you want to view.

— To view a notification associated with the component, on the Notifications tab click the link for the active ingredient that you want to view.

— To view the name of an active ingredient as it translates into other languages, click the Active Ingredient

Translations tab. Please note that only active ingredient translation values that are set to active in data administration will show on the tab.

— To view the alias of an active ingredient, click the Active Ingredient Aliases tab. Please note that only active ingredient alias values that are set to active in data administration will show on the tab.

— To view a reference active ingredient associated with the component active ingredient, on the Reference Active Ingredients click the link for reference active ingredient that you want to view.

Delete a Component

You can delete a component and associated active ingredients if you have the proper permissions. You can delete a component if:

— You have the appropriate security privileges to delete a component. If you have the rights to delete a product, you can delete a component.

— There are no notifications for the component, and no PDS templates or applications associated with the component's product.

To delete a component:

Navigate to the component that you want to delete.
Click a link for the component you want to delete.
The Component Attributes page opens.
Delete.
When you are prompted to confirm the deletion, click OK.

Manufactured Items for Components

The administrable pharmaceutical form of the product, as contained in the packaged medicinal product, is referred to as a Manufactured Item.

The manufactured items for a product are tracked at the component level. It is not mandatory for a component to have a manufactured item. To associate a manufactured item with a component:

— You must have the same user privileges required for adding a product.

— The component type must be pharmaceutical, pharmaceutical-medical device, flu vaccine or veterinary.

— The product family type for the associated product family must be flu vaccine, pharmaceutical, pharmaceuticalmedical device, or veterinary.

— A PDS template or an application must not be associated with the product.

Create a Manufactured Item

Create a manufactured item for the pharmaceutical, pharmaceutical-medical device, veterinary, and flu vaccine component types.

To create a manufactured item for a component:

Click the link for the component for which you want to create a manufactured item.
Click the Manufactured Items tab.
Click Create.
The Create Manufactured Item page opens.
Enter values for the manufactured item attributes. See Manufactured Item Attributes .
Save.

Manufactured Item Attributes

Description of the attributes used for manufactured items.

Use the following descriptions of manufactured items attributes to enter attribute values when creating or modifying a manufactured item. The attributes that are displayed depend on your security privileges.


Attribute	Description
Component Name	Name of a component.
Family Code	Code of the Product Family the component is associated to.
Family Name	Name of the Product Family the component is associated to.
Family Type	Type of the Product Family the component is associated to.
Attribute	Description
Manufactured Dose Form	The physical form in which a drug is produced and dispensed. This may be defined at the product level, component level, or both.
Manufactured Item Add Comment	Comments you want to share with others in a discussion thread. Comments are stamped with the date and time you enter the information, and your user ID.
Manufactured Item Characteristics/ Description	Text that describes the manufactured item or its characteristics.
Manufactured Item Comments	Existing comments.
Manufactured Item Concerned Parties	Users who may be copied on notifications about this entity; use semicolons (;) to separate e-mail addresses.
Manufactured Item Description	The description of manufactured item must be included whenever a medicinal product contains more than one pharmaceutical product.
Manufactured Item Keywords	Text you can use to search for the manufactured item.
Manufactured Item Name	The name of the manufactured item.
Manufactured Item Quantity	The quantity of the manufactured items in the medicinal product package, specified as a value and units (as per section 6.5 of the summary of product characteristics (SmPC)). For solid dose forms and other items measured by counting, discrete countable entities, the unit for quantity is “unit” and the “unit of presentation” is the item counted within the immediate container. For formulations contained in a vial, the unit for quantity is volume/quantity and the “unit of presentation” is the discrete countable entity, in which a pharmaceutical product or manufactured item is presented. You can enter both non-integer and integer values.
Manufactured Item Quantity Operator	Names of quantity operator values: Equal, Not Less Than, Range, Up to.
Manufactured Item Quantity Unit	Unit of quantity. This field displays values only from the Data Administration > Other > Unit of Measurement Values table.
Product Name	Name of the Product the component is associated to.
Unit of Presentation	Specifies the units the quantity of the manufactured item is presented in. Example: Bottle, Capsule, Tablet.

Modify a Manufactured Item

You can modify the values of the manufactured item attributes.

To modify the values of the manufactured item attributes:

Click a link for the manufactured item you want to modify.
On the Manufactured Item Attributes page, click Modify.
Enter your changes to the manufactured item attributes.
Save.

Delete a Manufactured Item

You can delete a manufactured item associated with a component.