CMO / Manufacturing
CMO technology transfer support
Transferring a granulated tablet process from a development site to a contract manufacturer.
Illustrative use caseIllustrative use case
External manufacturing partner identification
Finding and evaluating a qualified manufacturer for an oral solid product for a regulated market.
Challenge
The product owner had no manufacturing site and limited time to evaluate candidate organisations.
Requirement
A short-list of manufacturers with documented technical, quality and regulatory suitability.
Approach
Convert the product requirement into selection criteria, screen candidates, then evaluate the short-list through questionnaires, document review and audit planning.
Process & execution
- 1Requirement capture
- 2Selection criteria
- 3Long-list
- 4Screening
- 5Technical evaluation
- 6Quality assessment
- 7Recommendation
Technology / process
- Supplier qualification
- Audit planning
- Capacity assessment
Documentation
- Selection criteria matrix
- Evaluation report
- Audit plan
- Draft quality agreement
Verification
Evaluation scores and rationale reviewed and approved by the client quality unit.
Outcome / expected benefit
Expected benefit: a defensible manufacturer choice with the rationale on file.
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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