Tech Transfer
- Natalie Quan
- Jean Marie Schiraldi
- Adrienne O'Reilly
Table of Contents
Overview
Tech Transfer, short for Technology Transfer, refers to transferring knowledge, expertise, and technology from research and development (R&D) to commercial-scale production. Tech Transfer involves moving information about a pharmaceutical product or process between different teams and sites. For example, Tech Transfer is performed when scaling up or scaling out from the laboratory or pilot plant to a larger-scale manufacturing facility for commercialization.
Tech Transfer is a critical step in the pharmaceutical industry. It ensures the smooth transition of a drug candidate or therapeutic process from the development stage to large-scale production. It typically involves transferring various aspects, including formulation development, manufacturing processes, quality control procedures, and analytical methods.
QbDVision has a Tech Transfer tool that manages knowledge transfer and enables efficient information analysis between processes and sites. It is important to note that to perform a Tech Transfer within QbDVision, users must have at least one Process already added to their Project.
Video Tutorial
Key Concepts
Sending Site
This is the initial process that is being transferred. In the example above, the Sending Site is the initial 500L process copied to create the Receiving Site Process.
Receiving Site
This is the process to which the Sending Site is being transferred. Users can create the Receiving Site by copying it during the Tech Transfer process. Additionally, users can select another Process that has already been added to their project, such as the Receiving Site. In the example above, the Receiving Site was created by copying the Sending Site and renaming it the 1000L process.
Enable Receiving
This is required for the Process to be available as a Receiving Site to perform a Tech Transfer. Without Tech Transfer enabled, your Process will not be available in the Receiving Site dropdown during Tech Transfer Assessment.
Risk Management Plans
Risk Management Plans are a fundamental part of the Tech Transfer process, and proper setup of an RMP to facilitate Tech Transfer is required. Since Tech Transfer compares the same record types between processes, ensure the RMP used for the selected project has the By Type option enabled.
RMP Setup for Tech Transfer
With By Type enabled for the RMP, defining the appropriate Risk Schema for performing a Tech Transfer Assessment is now possible. Please note that Tech Transfer does not include Capability Risk as part of the Tech Transfer Assessment.
Transfer Risk Assessment
QbDVision’s Tech Transfer Assessment quickly identifies changes and potential gaps between the two processes. Columns can be filtered and sorted, similar to Dynamic Tables. To view Changes, hover over the Changes link for summary information.
Transfer Risk Assessment - Quick Edit
Each item (or row) in the Tech Transfer Assessment can be risk-assessed directly in line on the table.
For a more detailed view, select the Detailed Comparison, which provides information related to the changes and any Transfer Risk.
Tech Transfer Assessment - Recorded on Receiving Site
The Transfer Risk captured during the Tech Transfer Assessment activity is saved on the Receiving Site record. Scrolling down on the Receiving Site record, users will find the Tech Transfer section with the Transfer Risk information.
Process Linking Behavior
Automatic Linking (Initial Setup):
If you copy the Sending Process to create the Receiving Process and then turn on Tech Transfer in the Receiving Process, the system automatically links all the parts (e.g., attributes and components) of the two processes.
Manual Linking (After Adding New Elements):
However, if you add a new element to either process after you've turned on Tech Transfer, the automatic linking doesn't catch it.
In this case, you must manually tell the system to connect the new part in the Receiving Process to the corresponding new part in the Sending Process.
Think of it like adding a new ingredient to your recipe. You have to tell the copy of the recipe that this new ingredient needs to be there too.
In simpler terms:
Tech Transfer automatically links everything that was there when you turned it on.
Anything added later needs to be manually linked.
Change Criteria
The Change column indicates the differences between the Sending and Receiving Site records for the selected Change Criteria.
View Change Criteria
The Change Criteria are used to compare the Sending and Receiving Site records. Admins and Super Users can edit the change criteria by project and record type by clicking View Change Criteria from the Detailed Comparison view.
Change Criteria can be updated, cleared, or reset to the default.
The red dot icon to the left of the property name indicates Active Change Criteria.
Underlying Changes
Underlying changes are changes that exist between the Sending and Receiving Site records but are not part of the Change Criteria. They are also noted in the Changes column and indicated with a gray dot.
Ignore Changes
When there are non-impacting changes between the Sending and Receiving Site records, users can select Ignore Changes.
This will indicate there are no changes in the Changes column. The Ignore Changes filter will be reset when the Sending or Receiving Site record is changed.
Frequently Asked Questions
Why can’t I see my Receiving Site Process during Tech Transfer?
The Enable Receiving check box has not been set on your Receiving Site Process.
Why is my Tech Transfer Assessment showing High Impact on a row where there is no change?
Please check your RMP and confirm that it is using the “Allow ‘Not Assessed’ Scoring” option.