PDS Package Detail Attributes

You can use the attributes to describe product packaging associated with a PDS.

Attribute Description

Application

Code

The code of the application which this PDS is associated.

Application

Name

The name of the application which this PDS is associated.

Com­

ponent

Name

Component name of the component to which this packaging detail is associated.

Com­

ponent

Quantity

The quantity of the component. This attribute is specified as a value and a unit. The unit is specified as a symbol and a symbol identifier, as defined in ISO 11240 and the resulting controlled vocabulary.

Com­

ponent

Quantity

Unit

The unit used to specify the component quantity.
Attribute Description

Data

Carrier

Identifier

The individual value from the identification system that applies to the packaged Medicinal Product.

Date

QC'd

The date the QC Status was set.

Device

Quantity

The number of devices for packaging details. This field is displayed after the Medical Device Reference when Product has Med Device or PharmaMed Components.

Device

Quantity

Operator

Names of quantity operator values: Equal, Not Less Than, Range, Up to.

Device Quantity Unit of

Presentation

Represents a qualitative concept that describes a countable entity. Example: capsule, pack, aerosol.

Device Quantity Unit

of Measurement

Represents a standard for measurement of the device. Example: milliliter, milligram, gram.

Family

Code

The code of the product family which this PDS is associated.

Family

Name

The name of the product family which this PDS is associated.

Manu­

factured Item Reference

Reference to the manufactured item. The values available for selection is a concatenation of the following from the Manufactured Item entities associated with the PDS Product:<Manufactured Item Name>

<Unit of Presentation> <Manufactured Item Quantity> <Manufactured Item Quantity Unit of Measure>

<Manufactured Item Dose Form> <Manufactured Item Characteristics>

Medical

Device Reference

Reference to the medical device in the PDS. This field is only available for Med Dev and Pharma Med Dev components.

Package

Item Al­

The alternate material(s) of the package item.
Attribute Description

ternate

Material

Package Item Compo­

nent(s)

Package Components available for selection. It is a concatenation of Component Type and Component

Material. (For example: Stopper – Rubber)

Package Item Ma­

terial

The material(s) of the package item.
Package Item Quantity The quantity of the containers containing the packaged item.

Package

Item - MI

Quantity

The unit used to define the Packaging Manufacturer Item quantity. You can enter both integer and noninteger values.

Packaging MI

Quantity

Operator

Names of quantity operator values: Equal, Not Less Than, Range, Up to.

Package

Item - MI

Quantity

Unit

Units of Measurement Values or Units of Presentation Values in the Data Administration.

Package Item Quantity

Operator

Names of quantity operator values: Equal, Not Less Than, Range, Up to.

Package Item

Type

The kinds of packaging associated with the selected packaging category.

Package Set

Name

Name of the Package Set.
Attribute Description
Packaging Comments Text about the entity.
Packaging Category Category which this packaging belongs to.Note: You cannot create more than one Packaging with the same Packaging Category and Packaging Type.
Packaging Description Text that describes the PDS detail.
Packaging Keywords Words you can use to search for the entity.
Packaging Status The status of the entity.
Packaging Status Date The date the entity status is effective.

Parent

Package

Displays values previously added to the Packaging Type Values Data Administration list.

Product

Name

Full concatenated product name to which the PDS/Template is associated.

Product De­

tail Set

Name

The name for the PDS which this detail is associated.
QC'd by Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed.
QC Status QC Status of the detail.
Unit of Presentation The unit of presentation is a qualitative term describing the discrete unit in which a component is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and the resulting terminology.