Manufacturing / CMO
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Illustrative use caseIllustrative use case
Technology transfer documentation
Building a complete documentation set for transferring a product between sites.
Challenge
Previous transfers had missing documents discovered late at the receiving site.
Requirement
A standard transfer document set with checklist and ownership.
Approach
Define the transfer document list by function, templates and a readiness checklist.
Process & execution
- 1Document inventory
- 2Templates
- 3Ownership
- 4Readiness checklist
- 5Transfer review
Technology / process
- ICH Q10 knowledge management
- Document control
Documentation
- Transfer protocol template
- Readiness checklist
- Transfer report template
Verification
Checklist applied to a transfer and gaps closed before exhibit batches.
Outcome / expected benefit
Expected benefit: predictable transfers without late surprises.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use case
Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use case