PDS Package Detail Attributes
| Attribute | Description |
|---|---|
| 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. |
| Application Code | The code of the application which this PDS is associated. |
| Application Name | The name of the application which this PDS is associated. |
| Product Name | Full concatenated product name to which the PDS/Template is associated. |
| Product Detail Set Name | The name for the PDS which this detail is associated. |
| Package Set Name | Name of the Package Set. |
| Component Name | Component name of the component to which this packaging detail is associated. |
| 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 Type | The kinds of packaging associated with the selected packaging category. |
| Package Item Container Quantity | The quantity of the containers containing the packaged item. |
| Packaging Status | The status of the entity. |
| Packaging Status Date | The date the entity status is effective. |
| Data Carrier Identifier | The individual value from the identification system that applies to the packaged Medicinal Product. |
| Package Material | The material(s) of the package item. |
| Package Alternate Material | The alternate material(s) of the package item. |
| Component 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. |
| Component Quantity Unit | The unit used to specify the component quantity. |
| 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. |
| Package Components | Package Components available for selection. It is a concatenation of Component Type and Component Material. (For example: Stopper – Rubber) |
| Manufactured 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> |
| Packaging MI Quantity | The unit used to define the Packaging Manufacturer Item quantity. You can enter both integer and non-integer values. |
| Packaging MI Quantity Unit | Units of Measurement Values or Units of Presentation Values in the Data Administration. |
| Medical Device Reference | Reference to the medical device in the PDS. This field is only available for Med Dev and Pharma Med Dev components. |
| 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 Unit | The name of the unit defining the device quantity. Example: capsule, pack, aerosol. |
| QC Status | QC Status of the detail. |
| Date QC'd | The date the QC Status was set. |
| QC'd by | Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed. |
| Packaging Keywords | Words you can use to search for the entity. |
| Packaging Description | Text that describes the PDS detail. |
| Packaging Comments | Text about the entity. |