What does Technology Transfer mean to you?
You have put a lot of work into developing a new drug substance and drug product. Pre-clinical studies have been successful, and you have the necessary investment needed for your first clinical trial. You need to outsource manufacture of your drug product and have selected the companies you’re going to use. Regular communication with your vendors is essential to ensure that you and your service provider’s requirements and learnings are clearly understood by the other party.
How will your product knowledge be transferred to your chosen contract manufacturing and test companies?
Documenting key controls that have been determined during development and providing essential documents to your manufacturer facilitates transfer of knowledge. This documentation can be used for checking materials required, manufacturing process controls and test methods in preparation for the first batch which may be an engineering run.
How will learnings during manufacture set up be transferred back to the sponsor?
Documenting learnings from batches manufactured, particularly from the first engineering runs, ensures that these learnings do not get forgotten and can easily be referenced when changes are made later in the product lifecycle, for example during scale up.
How do you ensure all knowledge is traceable throughout a product’s lifecycle?
Maintenance of a Product Knowledge File which references all key product-specific controls and associated reports, will ensure that knowledge gained throughout the product’s life is traceable, and can be referenced during investigation.
Is your product knowledge effectively organised?
We can help you design appropriate documents for your knowledge files that will support transfer of information to your service providers.
Contact us to arrange a no obligation discussion on your product knowledge documentation (firstname.lastname@example.org)