TECHNICAL INSIGHT / CDMO
Choosing an API manufacturing partner: questions to ask early
A practical conversation framework for sourcing teams evaluating a potential CDMO. Project-specific technical and regulatory assessment remains essential.
1. Define the product and the manufacturing stage
Start with the exact material identity, salt or solid form where relevant, intended market, development stage, anticipated batch size and timeline. Request the specification and available analytical methods before comparing offers. A shared description of starting materials and responsibilities helps establish a meaningful scope.
2. Discuss process understanding and transfer
Ask what process knowledge can be transferred, which unit operations require particular controls, and how the receiving site will evaluate scale and equipment fit. Agree on the documentation, analytical method transfer and change-control responsibilities needed for the project.
3. Examine quality and regulatory fit
Review the proposed site's quality system, relevant inspection history and documentation for the intended market. The ICH Q7 guideline provides a GMP framework for APIs used in human medicines; applicability and implementation should be evaluated for the specific operation and jurisdiction.
4. Plan validation over the lifecycle
The FDA describes process validation as a lifecycle spanning process design, qualification and continued process verification. Discuss what evidence is available for the intended stage and how process performance will be monitored; this overview does not replace the full guidance or a regulatory assessment.
5. Align commercial and technical expectations
Confirm ownership of materials, quality agreements, forecast volumes, lead times, confidentiality and the approach to deviations. Compare proposals against the same written requirements rather than price alone.
Sources and further reading
- ICH quality guidelines, including Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- FDA: Process Validation: General Principles and Practices
This guide is general information and is not a claim that LentoTech owns a manufacturing facility or holds any specific certification.