Questions to Ask During CDMO Site Audits

A site audit is your opportunity to verify claims and assess cultural fit.

Quality Systems Questions

1. How do you handle deviations and CAPA?
2. What is your batch failure rate?
3. How are OOS investigations conducted?

Manufacturing Questions

1. What is your typical batch success rate?
2. How do you handle technology transfer?
3. What is your scale-up approach?

Project Management

1. Who will be our primary contact?
2. How often do you provide updates?
3. How do you handle scope changes?

Supply Chain

1. Where do you source raw materials?
2. How do you qualify suppliers?
3. How do you handle supply disruptions?