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. |
