Drug Substances & Drug Products
- Natalie Quan
- Adrienne O'Reilly
- Jean Marie Schiraldi
Table of Contents
Overview
Drug Substances and Drug Products can be created and managed in the Product module. Creating multiple Drug Substance and Drug Product records enables product variation and flavor management. Each record represents a variation, which can be distinguished by the Final Quality Attributes that are associated with that variation. Additionally, each variation can be related to the Process used to produce the Drug Substance or Drug Product.
Video Tutorial - DS/DP Overview
Key Concepts
Adding a Drug Substance/Drug Product to a Process
Users can add a Drug Substance/Drug Product record to an existing Process using the Relationship to Process section in the record. Users can select the Process, Unit Operation, and/or Step from which the Drug Substance/Drug Product is produced. Today, users will only be able to select one Process per Drug Substance or Drug Product, and by default, they will be added as Output Materials. Once added to a Process, users will be able to access the record in the Process Explorer Tree view.
Navigate to the Product tab and then choose Drug Substance/Drug Product
Click the “Add” button, then select Drug Substance
Name: B-mAb DS Flavor 1
Description: B-mAb DS Flavor 1 is the drug substance for the monoclonal antibody product that targets and neutralizes the B protein for the ABC Disease
Scroll down to Relationship to Process
Choose Output
Select the appropriate Process, Unit Operation, and Step
Scroll down to Attributes
Click the + sign to choose one more Final Quality Attributes by placing a checkmark in the box
Click Save Draft
Spec Management
Video Tutorial - DS/DP Specification Management
Key Concepts
Adding to the Attributes Table
To distinguish between Drug Substance and Drug Product variations, users can use the Attributes table in the record to list all of the Final Quality Attributes that are associated with the specific product variation or flavor. To do this, users can follow the steps listed below:
In a Drug Substance or Drug Product record, navigate to the Attribute table section
Select “Add Final Quality Attribute”
Select at least one Final Quality Attribute listed and click “Add”
Save the Drug Substance or Drug Product record
Creating & Linking Intermediate Quality Attributes to Final Quality Attributes
Intermediate Quality Attributes can be created and linked to Final Quality Attributes through Drug Substances and Drug Products. Linking an Intermediate Quality Attribute to a Final Quality Attribute creates a reference between the records so that the Acceptance Criteria ranges of the Final Quality Attribute are viewable in the linked Intermediate Quality Attribute record. This makes it easy for users to view the values determined by the Product definition while defining their Process. To link an Intermediate Quality Attribute to a Final Quality Attribute, users are required to have added the Drug Substance/Drug Product to a Process, and at least one Final Quality Attribute to the Attributes table in the Drug Substance/Drug Product record. For instructions on how to fulfill these requirements, please refer to the Key Concepts described above.
Users will have the option to: A) create a linked Intermediate Quality Attribute from a Final Quality Attribute or B) link an existing Intermediate Quality Attribute to a Final Quality Attribute. Both options are detailed below.
A) To create a linked Intermediate Quality Attribute from a Final Quality Attribute, follow these steps:
In the Attributes table, select “Add Intermediate Quality Attribute”
Edit the name of the new record, if required.
Leave the toggle option selected so that the new record will be linked.
Click “Create” to add the new linked Intermediate Quality Attribute record.
B) To link an existing Intermediate Quality Attribute to a Final Quality Attribute, follow these steps:
In the Intermediate Quality Attribute that is associated with the Drug Substance/Drug Product, click “Link to Final Quality Attribute”.
Select the Final Quality Attribute and click “Add”.
Unlinking Intermediate Quality Attributes from Final Quality Attributes
Users can unlink the linked Intermediate Quality Attribute by following these steps:
Navigate to the linked Intermediate Quality Attribute record.
Select the “…” in the banner at the top of the record.
Click “Unlink”, then confirm by selecting “Unlink” in the pop-up window.
Frequently Asked Questions
What happens to Final Quality Attributes (FQAs) listed in the Attributes section when the record is archived?
Upon archiving, the system will automatically remove the relationships established between the Drug Substance/Drug Product and Final Quality Attributes. Additionally, all linked Intermediate Quality Attributes listed in the Attributes table will be unlinked. Users will be required to re-add the Final Quality Attributes and re-link Intermediate Quality Attributes in the Drug Substance/Drug Product Attribute table when the record is restored.