Product Detail Set Maintenance

Product detail set (PDS) values appear in lists on the Product Detail Set, Product Detail Set Details, Product

Detail Set Template, and Product Detail Set Template Details Attributes pages and are designated when a PDS, PDS detail, PDS template, or PDS template detail is created.

Data administration enables you to add and modify list values, and to set the status of a value to active or inactive. When you select a value under Product Detail Set Maintenance, a page appears with a table of all values that have been defined. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

The proper data administration access privileges are required to view and modify application maintenance values.

Note: Twenty extra text fields, five extra date fields, and five extra number fields can be configured for all PDS values.

Product Detail Set Maintenance: PDS Values

You can create and maintain the following PDS values:


Value	Description
Color	The color of the component color
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.
Component Type	The type of component. The RMS value is mapped to the Сontainer Category SPOR RMS List.
Device - Type of Combination	The type of the device. The RMS value is mapped to the Medical Device Legislative Category SPOR RMS List.
Dose Frequency	The frequency of the dose administered. Used for veterinary products.
Genetically Modified Cell Origin Species	Species from which cells have been genetically modified.
	*Note:* By default, the section is hidden.

Human Consumption Product	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.
Intended Effect	Expected result of the drug. The RMS value is mapped to the Medicine Profile SPOR RMS List.
Label Type	The type of label. For example, patient insert, physician insert, carton label, package label, etc.
Manufacturer	The name of the manufacturer. Substances, manufacturer functions, material and packaging The following Detail Types must exist under Global Detail Sets to associate Global Product Details with a manufacturer: — Substance — Manufacturer Functions — Material — Packaging
Manufacturing Functions	The functions associated with the manufacturing Example: dosage form production, dosage form retesting, repackaging, etc.


Value	Description
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.
Package Component	The type pf packaging component values.
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.
	*Note:* By default, the section is hidden.

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.


Value	Description
Somatic Cell Therapy Cell Type	Types of somatic cells used in a trial.
	*Note:* By default, the section is hidden.

Somatic Cell Therapy Origin Species	Species from which somatic cells are derived.
	*Note:* By default, the section is hidden.

Somatic Cell Therapy Origins	Origination of somatic cells in a trial.
	*Note:* By default, the section is hidden.

Source of Scientific Advice	Used in a trial.
	*Note:* By default, the section is hidden.

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	Indicates the substance type in the Product Detail Set. The different Substance Types available are - Adjuvant and Excipient. The default value is set to Active. The standard set of extra fields can be configured for this value. The RMS value is mapped to the Ingredient Role SPOR RMS List.
Time Unit	Example: month, week, day
Type of Dossier Submitted	Example: full IMPD, simplified IMPD, and SmPC
	*Note:* By default, the section is hidden.

Value	Description
Type of Gene Therapy Transfer Product	Example: nucleic acid naked, nucleic acid, complexed, viral vectoradenovirus, viral vector-retrovirus, viral vector-AAV
	*Note:* By default, the section is hidden.

Type of Gene Therapy	Example: in-vivo, ex-vivo
	*Note:* By default, the section is hidden.

Type of Genetically Modified Cell Origin	Origination of genetically modified cells.
	*Note:* By default, the section is hidden.

Volume Unit of Measure	The volume can be specified using a numerical value and its unit of measurement.
Medical Device UDI Values	A Unique Device Identification (UDI) system identifies the medical devices with it's usage. This table displays the values for the Device Type field for PDS Component - Medical Devices. This Data Administration list is mapped to the Device Type value in the SPOR RMS list section.
Origin of Substance	The list of substance sources required for IDMP.
Manufacturing Function	This Data Administration table is used to populate the Function Name field for PDS- Function. This Data Administration list is mapped to the Manufacturing Activity value in the SPOR RMS list section.
Data Classification Type	This Data Administration table is used to populate the Confidentiality Indicator field on the Data Administration Manufacturer Values - Data Administration Manufacturer Values > Global Product Details > Global Detail Sets.

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


Attribute	Description
Color	Color value.
Last User Updated	Indicates the name of the user who last created/updated the color. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
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 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	Indicates the name of the user who last created/updated the compendial designation/source value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Component Type Attributes

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


Attribute	Description
Component Type Name	The Type of the component.
RMS Term Name	List of Container Category RMS Values available for selection.
Last User Updated	Indicates the name of the user who last created/updated the component type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Device - Type of Combination Attributes

To define a type of the device values, enter values for the following attributes:


Attribute	Description
Device - Type of Combination Name	The name of the device type.
RMS Term Name	List of Medical Device Legislative Category RMS Values available for selection.
Last User Updated	Indicates the name of the user who last created/updated the device type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the dose frequency. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the genetically modified cell origin species values. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the genetically modified human consumption products value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Intended Effect Attributes

To define an intended effect value, enter values for the following attributes:


Attribute	Description
Intended Effect	Expected result of the treatment.
RMS Term Name	List of Medicine Profile RMS Values available for selection.
Last User Updated	Indicates the name of the user who last created/updated the intended effect value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the label type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.
Labeler DUNS Number/Legal Manufacturer Single Registration Number(SRN)	Indicates the Labeler DUNS Number for US and the Manufacturer Single Registration Number (SRN) for EU.
Authorized Representative Name	Name of the authorised representative of the Manufacturer.
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	Name of the agent.
Agent Title	Title of the agent.
Agent Address	The address of the agent.
Agent Phone	Agent phone number.
Agent Fax	Agent fax number.
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.
Attribute	Description
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.
Organization ID	The organization identifier associated from SPOR Master Lists > Organization.
Location ID	The location identifier associated from SPOR Master Lists > Organization.
Manufacturer Name	The organization name associated from SPOR Master Lists > Organization.
Address	The address associated from SPOR Master Lists > Organization.
City	The city associated from SPOR Master Lists > Organization.
Post Code	The post code associated from SPOR Master Lists > Organization.
Country	The country associated from SPOR Master Lists > Organization.
Last User Updated	Indicates the name of the user who last created/updated the manufacturer. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Flag	Indicates if the entity is active or inactive.
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. For example, Stability Testing, PreDosage Processing.
Last User Updated	Indicates the name of the user who last created/updated the manufacturing functions. By default, this option is read-only. It is populated automatically when updates were made to the table.
Attribute	Description
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the material type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the material. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.
Attribute	Description
Last User Updated	Indicates the name of the user who last created/updated the medical device part code. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Package Component Attributes

To define a package component, enter values for the following attributes:


Attribute	Description
Component Type	Value of the Component type from the Data Administration > Component Type Values .
Product Material	Value of Product Material from the Data Administration > Product Material Values .
Package Component Name	Name of the Package Component. Package Components name is displayed as a concatenation of Component Type and Component Material. Example: CompType1-Material1
Last User Updated	Indicates the name of the user who last created/updated the package component value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.

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.
IDMP Package Level	IDMP Package Level defined in numbers and characters. For example: 123/456/78Z.
Last User Updated	Indicates the name of the user who last created/updated the packaging category. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the packaging type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the product bio type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Select which of the added statuses will show for a Product Detail Set status after the Event is closed.
Attribute	Description
Internal System Status	The internal status associated to the PDS status.
Last User Updated	Indicates the name of the user who last created/updated the product detail set status. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the product material. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the product type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.
Attribute	Description
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	Indicates the name of the user who last created/updated the QC status. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the shape value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the shelf life category. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the shelf life type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the somatic cell therapy cell types. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the somatic cell therapy origin species value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the somatic cell therapy origin value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the source of scientific advice. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the species. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the storage condition. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the substance role. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.
RMS Term Name	Name of the RMS term used to describe attributes of products.
Last User Updated	Indicates the name of the user who last created/updated the substance type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the time unit. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the type of dossier submitted. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the type of gene therapy transfer product. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the type of gene therapy. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the type of gene therapy modified cell origin. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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	Indicates the name of the user who last created/updated the volume unit of measure. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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 UDI Attributes

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


Attribute	Description
Medical Device UDI Name	Unique name for the Medical Device UDI.
Last User Updated	Indicates the name of the user who last created/updated the medical device UDI. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Origin of Substance Attributes

To define an origin of substance value, enter values for the following attributes:


Attribute	Description
Origin of Substance	Unique name for the substance source.
Last User Updated	Indicates the name of the user who last created/updated the substance source. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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 Function Attributes

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


Attribute	Description
Manufacturing Function Name	Unique name for the Manufacturing Function.
Last User Updated	Indicates the name of the user who last created/updated the manufacturing function. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Data Classification Type Attributes

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


Attribute	Description
Data Classification Type Name	Name for the Data Classification Type.
Last User Updated	Indicates the name of the user who last created/updated the data classification type. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. 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.

Associate Product Details with a Manufacturer

You can associate product details with a manufacturer in Data Administration.

To associate product details with a manufacturer:

Choose Go To > Data Administration.
Under Product Detail Set Maintenance, click Manufacturer Values.
Click the manufacturer for which you want to make an association.


Option	Action
To associate a type of global product detail with the manufacturer:	Click next to Global Product Details. Select the type in Detail Type drop-down list.
To associate a manufacturing authorization reference number with the manufacturer:	Сlick next to Manufacturing Authorization Reference Number.
To save the changes:	Click Save for each page.

Manufacturer Entities

Global Product Details Attributes

Use the global product details option to create global detail sets to display general information about manufacturer, good manufacturing practices statuses and expiration dates ,drug master file number detail type and so on.

You can define the following Global Detail Sets values:


Attribute	Description
Manufacturer Name	Name of the manufacturer.
Address Line 1	Address of the Manufacturer.
Country	Country of the Manufacturer.


Attribute	Description
Country Code	Country Code based on site address.
GMP Status	Status of the Manufacturer with respect to Good Manufacturing Practices. For example, In Good Standing, Not in Good Standing, and so on.
GMP Expiration Date	Date on which the GMP status is expected to expire before the Manufacturer needs to renew.
Last GMP Inspection	Date of the last GMP inspection.
Comments	Comments for Global Detail Sets.
Keywords	Keywords used to search Global Detail Sets .
Description	Description for Global Detail Sets.
Detail Type	Type of Manufacturer PDS Detail: Substance, Material, Manufacturing Functions, Packaging.
Substance Name	Name of the Substance. Available when the Detail Type is a Substance. You can select only one substance.
DMF Number	The number for the Drug Master File that is used to submit data to regulatory authorities for review and approval of a drug. Available when the Detail Type is a Substance.
Raw Material	The name of Material. Available when the Detail Type is a Material.
Function	The name of Manufacturing Functions. Available when the Detail Type is Manufacturing Functions.
Confidentiality Indicator	The Confidentiality Indicator is populated by the Data Classification SPOR RMS list. Available when the Detail Type is Manufacturing Functions, Substance and Packaging.
Category	The Category of Packaging. Available when Detail Type is a Packaging.
Packaging	The type of Packaging. Available when Detail Type is a Packaging.
Last User Updated	Indicates the name of the user who last created/updated the global detail set value. By default, this option is read-only. It is populated automatically when updates were made to the table.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table.
Active Flag	Current Active/Inactive setting for the Global Detail Set.

Manufacturer Authorization Reference Number Attributes

Use Manufacturer Authrorization Reference Number option to display general information about manufacturer, good manufacturing practices statuses and expiration dates, information when the last GMP inspection took place, contact details and so on.

Note: You can create multiple Manufacturing Authorization Reference Number entities with the same name, type, and effective date, but the Function Types or Substances fields should contain different values.

You can maintain the following Manufacturer Authorization Reference Number values:


Attribute	Description
Active Flag	Current Active/Inactive setting for the Global Detail Set.
Address Line 1	Address of the Manufacturer.
Agent	Name of the agent.
Agent Title	Title of the agent.
Agent Address	The address of the agent.
Agent Phone	The phone number of the agent.
Agent Fax	The fax number of the agent.
Agent e-mail	Agent email address.
Authorised Representative Name	The name of Authorised Representative.
Comments	Comments for Manufacturer.
Contact Person	Name of the contact person.
Contact Person Title	Title of the contact person.
Country	Country Code based on site address.
Country	The country that approved the manufacturing site. When country is selected, choose the related Regulatory Agency associated to the country, otherwise the country value is not saved.
Description	Description for Manufacturer.
DMF/CEP Number	The number of Drug Master File (DMF)/Certificate of Suitability (CEP). Issued by the authorities when the manufacturer of a drug provides relevant proof for the drug quality.
e-mail	Contact person email address.
Effective Date	The organisation name associated with SPOR OMS.
Fax	Fax number.


Attribute	Description
FEI Number	FDA Established Identifier.
GMP Status	Status of the Manufacturer with respect to Good Manufacturing Practices. For example, In Good Standing, Not in Good Standing and so on.
GMP Expiration Date	Expiry date of the GMP.
Keywords	Keywords used to search information.
Labeler DUNS Number/ Legal Manufacturer Single Registration Number (SRN)	Indicates the Labeler DUNS Number for US and the Manufacturer Single Registration Number (SRN) for EU.
Last GMP Inspection	Date of the last GMP inspection.
Last Changed Date	Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates are made to the table.
Last User Updated	Indicates the name of the user who last created/updated the manufacturing authorization reference number value. By default, this option is read-only. It is populated automatically when updates are made to the table.
Function Types	The list of function types taken from Manufacturing Authorisation Reference Number > Global Product Details.
Substances	The list of substances taken from Manufacturing Authorisation Reference Number > Global Product Details.
Manufacturer Name	Name of the Manufacturer.
Manufacturing Authorisation Reference Number	The organisation identifier associated with SPOR OMS.
Manufacturing Authorisation Type	The location identifier associated with SPOR OMS.
Other Firms	Other firms operating at site.
Parent Company Name	Name of the parent company.
Phone	The phone number of the contact person.
Regulatory Agency	Data Administration values assigned in Application Maintenance > Country Values > Health Authrority.The regulatory agency must be selected for the country..
Site License Number	The license number of the site.
Site Certificate Filed	Indicates if site certificate is available or not.
Status Type	The type of status: Active or Inactive.


Attribute	Description
Status Date	The effective date for the current status.
US Agent	The name of the US Agent.

Modify an Association with a Manufacturer

You can modify the manufacturer associated with a product detail in Data Administration.

To modify a product detail association with a manufacturer:

Choose Go To > Data Administration.
Under Product Detail Set Maintenance, click Manufacturer Values.
Click the manufacturer you want to modify.

Scroll to the bottom of the page and click the global product detail you want to modify, and proceed as follows:


Action	Procedure
To deactivate an association with a manufacturer	Click the Active Flag arrow and choose Inactive.
To reactivate a deactivated association with a manufacturer	Click the Active Flag arrow and choose Inactive.

Click Save.
Click Back to return to the Manufacturers page.