Product Detail Set Maintenance: PDS Values

You can create and maintain the following PDS values:

Value	Description
Color	Component color, such as red, blue, pink, and so on.
Compendial Designation/Source	Contains information for each reference source that will be stored directly in the XEVMPD. Must contain all values for which approval is requested or given. A value can be, for example, USP, PhEUR, or JP. The list contains reference sources (compendial designations) from the EMA reference sources CV. The default value is set to Active. The standard set of extra fields can be configured for this value.
Dose Frequency	Used for veterinary products, this is how often a dose is administered in a dosing schedule.
Genetically Modified Cell Origin Species	Species from which cells have been genetically modified.
Human Consumption Product	Used for veterinary products, this indicates whether a product produced from an animal is not to be used by humans while a drug is administered, or is considered safe for humans to use after a withdrawal period.
Label Type	Example: patient insert, physician insert, carton label, package label, etc.
Manufacturer	Companies that perform manufacturing functions. Substances, manufacturer functions, material and packaging must exist in the system to be able to associate them with manufacturers.
Manufacturing Functions	Example: dosage form production, dosage form retesting, repackaging, etc.
Material Type	Used to add material types to the system, such as by-product, raw material, or intermediate. Can also deactivate active material types.
Material	The substance or substances out of which a thing is or can be made.
Medical Device Part Code	Identification codes assigned to parts of medical devices.
Packaging Category	Example: primary, secondary
Packaging Type	Example: blister, glass bottle, plastic bottle
Product Bio Type	Type of biologic or technobiologic product, such as extractive, recombinant, vaccine, GMO, plasma derived, etc.
Product Detail Set Status	Example: approved, in-progress, withdrawn, and not approved
Product Material	The material out of which the product is made.
Production Type	Used for veterinary products, production types are the varieties of a species for which a drug is targeted. Multiple production types can be associated with a species, and a production type can be associated with multiple species. If a production type is used in the dosing schedule detail for a species in a PDS or PDS template, do not disassociate the production type from the species.
QC Status	The QC (quality control) status that you can assign to a pending PDS detail to indicate whether it has been checked to verify that it is correct. The default QC Status values are: Not Applicable (QC statuses are not used), QC Passed, QC Failed, and Not QC’d (not checked).
Shape	Component shape, such as oval, round, etc.
Shelf Life Category	The kind of shelf life for a product. For example, a category can be registered, for an actual product shelf life that is registered with the registration authority, or labeled, for a shelf life that is on the product package label.
Shelf Life Type	This describes the shelf life, taking into account various scenarios such as shelf life of the packaged medicinal product itself, shelf life after transformation where necessary and shelf life after the first opening of a product, etc.
Somatic Cell Therapy Cell Type	Types of somatic cells used in a trial.
Somatic Cell Therapy Origin Species	Species from which somatic cells are derived.
Somatic Cell Therapy Origins	Origination of somatic cells in a trial.
Source of Scientific Advice	Used in a trial.
Species	Used for veterinary products, species types are the animals for which a drug is targeted. Production types must exist in the system to be able to associate them with a species.
Storage Condition	Conditions approved for packaging.
Substance Role	Name of a role that can be associated to an Substance Detail in a Product Detail Set. For example, colorant, filler, etc. The default value is set to Active. The standard set of extra fields can be configured for this value.
Substance Type	Defines the type of the substance that you want to use in your Product Detail Set. There are 2 Substance Types available for you to choose - Adjuvant and Excipient. The default value is set to Active. The standard set of extra fields can be configured for this value.
Time Unit	Example: month, week, day
Type of Dossier Submitted	Example: full IMPD, simplified IMPD, and SmPC
Type of Gene Therapy Transfer Product	Example: nucleic acid naked, nucleic acid, complexed, viral vector-adenovirus, viral vector-retrovirus, viral vector-AAV
Type of Gene Therapy	Example: in-vivo, ex-vivo
Type of Genetically Modified Cell Origin	Origination of genetically modified cells.
Volume Unit of Measure	The volume can be specified using a numerical value and its unit of measurement.

Color Attributes

To define a color value, enter values for the following attributes:

Attribute	Description
Color	Color value.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Compendial Designation/Source Attributes

To define a compendial designation/source value, enter values for the following attributes:

Attribute	Description
Compendial Designation/Source Name	Contains reference sources (compendial designations) from the EMA reference sources CV.
Date Submitted to EMA	Date Submitted to EMA populated automatically when Acknowledgement Wizard passed.
EV Code	Code assigned by the EMA to this Compendial Designation.
RMS Term Name	List of Active Compendial Designation/Source RMS Values available for selection.
XEVMPD Comments	Comments field. For EMA submissions, comments must be limited to 500 characters. Comments are mandatory for the Nullify operation type.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Dose Frequency Attributes

To define a dose frequency value, enter values for the following attributes:

Attribute	Description
Dose Frequency	Dose Frequency. Example: Single Administration.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Genetically Modified Cell Origin Species Attributes

To define a genetically modified cell origin species value, enter values for the following attributes:

Attribute	Description
Genetically Modified Cell Origin Species	Genetically Modified Cell Origin Species.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Human Consumption Products Attributes

To define a human consumption products value, enter values for the following attributes:

Attribute	Description
Human Consumption Products	Human Consumption Products. Examples: Milk, Meat.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Label Type Attributes

To define a label type value, enter values for the following attributes:

Attribute	Description
Label Type	Name of the type of label. Example: Package Insert, Carton Label.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Manufacturer Attributes

To define a manufacturer value, enter values for the following attributes:

Attribute	Description
Manufacturer Name	Name of the Manufacturer. Uniqueness by concatenation: Manufacturer Name + Address Line 1 + Country.
Organisation Identifier	Organisation Identifier so that RIM code could be mapped to the IDMP code.
Address Line 1	Full address of the Manufacturer.
Country	Country Code based on site address. Data from Data Administration >Country Values.
GMP Status	Status of the Manufacturer respectively to Good Manufacturing Practices. Example: In Good Standing, Not in Good Standing
GMP Expiration Date	Date on which the GMP status is expected to expire before the Manufacturer needs to renew.
Last GMP Inspection	Date on which the last GMP inspection took place.
Contact Person	Contact at the Manufacturer.
Contact Person Title	Contact person's title.
Phone	Full phone number.
Fax	Full fax number.
e-mail	Email address of contact.
Agent
Agent Title
Agent Address
Agent Phone
Agent Fax
Agent e-mail	Email address of contact.
Site License Number
Site Certificate Filed	check = yes
DMV/CEP Number
US Agent	Name of the US Agent.
FEI Number	FDA Established Identifier.
Parent Company Name	Name of the parent company.
Other Firms	Other firms operating at site.
Comments	Free format text box where users can enter information.
Keywords	Free format text box where users can enter text for searching purposes.
Description	Free format text box for entering descriptive information.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Manufacturing Functions Attributes

To define a manufacturing functions value, enter values for the following attributes:

Attribute	Description
Manufacturing Function Name	Full Manufacturing Function Name. Example: Stability Testing, Pre-Dosage Processing.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Material Type Attributes

To define a material type value, enter values for the following attributes:

Attribute	Description
Material Type	Material Type. Example: Raw Material, Intermediate, By-Product.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Material Attributes

To define a material value, enter values for the following attributes:

Attribute	Description
Material Name	Material Name.
Description	Description of the Material.
Comments	Internal comments including exceptions and clarifications.
Keywords	Free format text box where users can enter text for searching purposes.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Medical Device Part Code Attributes

To define a medical device part code value, enter values for the following attributes:

Attribute	Description
Medical Device Part Code	Material Type. Example: Raw Material, Intermediate, By-Product.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Packaging Category Attributes

To define a packaging category value, enter values for the following attributes:

Attribute	Description
Name	Name of the Packaging Category. Example: primary, secondary.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Packaging Type Attributes

To define a packaging type value, enter values for the following attributes:

Attribute	Description
Category	Selected Packaging Category associated to the packaging type.
Name	Name of the Packaging Type associated to a selected Category.
Description	Free format text box for entering descriptive information.
Comments	Free format text box where users can enter information
Keywords	Free format text box where users can enter text for searching purposes
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Bio Type Attributes

To define a product bio type value, enter values for the following attributes:

Attribute	Description
Product Bio Type	Is selected only when the product is considered to be biological or biotechnological. Values: Extractive, Recombinant, Vaccine, GMO, Plasma Derived.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Detail Set Status Attributes

To define a product detail set status value, enter values for the following attributes:

Attribute	Description
Name	The name given for the Product Detail Set Status.
Default Flag	Flag to indicate if the status value is the default.Yes and No values are available for selection.
System Process Default Flag	Enables you to select which of the added statuses will show for a Product Detail Set status after the Event has been closed.
Internal System Status	The internal status associated to the PDS status.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Product Material Attributes

To define a product material value, enter values for the following attributes:

Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Production Type Attributes

To define a production type value, enter values for the following attributes:

Attribute	Description
Production Type	Production Type. Examples: Breeders, Fatteners.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

QC Status Attributes

To define a QC status value, enter values for the following attributes:

Attribute	Description
Name	Name given for the QC Status.
Default Flag	Flag to indicate if the status value is the default.Yes and No values are available for selection.
Internal System Status	The internal status associated to the QC Status.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Shape Attributes

To define a shape value, enter values for the following attributes:

Attribute	Description
Shape	Defines a shape. Examples: Round, Oval.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Shelf Life Category Attributes

To define a shelf life category value, enter values for the following attributes:

Attribute	Description
Shelf Life Category	The Shelf Life Category identifies whether the Shelf Life being tracked in the PDS is the registered Shelf Life (approved by the Reg Authority) or the Shelf Life that appears on the product label.
Default Flag	Flag to indicate if the value is the default.Yes and No values are available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Shelf Life Type Attributes

To define a shelf life type value, enter values for the following attributes:

Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Somatic Cell Therapy Cell Types Attributes

To define a somatic cell therapy cell types value, enter values for the following attributes:

Attribute	Description
Somatic Cell Therapy Cell Types	Is selected only when Somatic Cell Therapy Origin is populated. Values are: Stem Cells, Differentiated Cells, Keratinocytes, Fibroblasts, Chondrocytes.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Somatic Cell Therapy Origin Species Attributes

To define a somatic cell therapy origin species value, enter values for the following attributes:

Attribute	Description
Somatic Cell Therapy Origin Species	Is selected only when Somatic Cell Therapy Origin is populated.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Somatic Cell Therapy Origins Attributes

To define a somatic cell therapy origins value, enter values for the following attributes:

Attribute	Description
Somatic Cell Therapy Origins	Is selected only when there is no genetic modification. Values are: Autologous, Allogenic, Xenogeneic.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Source of Scientific Advice Attributes

To define a source of scientific advice value, enter values for the following attributes:

Attribute	Description
Source of Scientific Advice	Source of Scientific Advice. Values are CHMP, MS Competent Authority, CHMP and MS Compentent Authority and none.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Species Attributes

To define a species value, enter values for the following attributes:

Attribute	Description
Species	Species. Examples: Cattle, Sheep.
Production Types	All active Production Types defined in Data Administration available for selection.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Storage Condition Attributes

To define a storage condition value, enter values for the following attributes:

Attribute	Description
Storage Condition	Name of the Storage Condition.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Role Attributes

To define a substance role value, enter values for the following attributes:

Attribute	Description
Name	Name of Substance Role. Examples: Not Applicable.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Substance Type Attributes

To define a substance type value, enter values for the following attributes:

Attribute	Description
Substance Type	Name of Substance Type. Examples: Adjuvant, Excipient.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Time Unit Attributes

To define a time unit value, enter values for the following attributes:

Attribute	Description
Time Unit	Name of Time Unit. Examples: Second(s), Minute(s), Hour(s), Day(s), Month(s), Year(s).
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Type of Dossier Submitted Attributes

To define a type of dossier submitted value, enter values for the following attributes:

Attribute	Description
Type of Dossier Submitted	Name of Type of Dossier Submitted. Examples: Full IMPD, Simplified IMPD, and SmPC.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Type of Gene Therapy Transfer Product Attributes

To define a type of gene therapy transfer product value, enter values for the following attributes:

Attribute	Description
Type of Gene Therapy Transfer Product	Name of Gene Therapy Transfer Product. Examples: Full IMPD, Simplified IMPD, and SmPC.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Type of Gene Therapy Attributes

To define a type of gene therapy value, enter values for the following attributes:

Attribute	Description
Type of Gene Therapy	Name of Gene Therapy. Examples: in-vivo, ex-vivo.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Type of Genetically Modified Cell Origin Attributes

To define a type of genetically modified cell origin value, enter values for the following attributes:

Attribute	Description
Type of Genetically Modified Cell Origin	Name of Type of Genetically Modified Cell Origin. Examples: Autologous, Allogeneic, Xenogeneic.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.

Volume Unit Of Measure Attributes

To define a volume unit of measure value, enter values for the following attributes:

Attribute	Description
Code Value	The actual value for the code.
Code Name	The full name and/or description for the code.
Last User Updated	Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Defines when the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active	Indicates if the entity is active or inactive.