How to Evaluate a CDMO’s Commitment to Quality

Published on: 
Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation, February 2024 eBook, Volume 2024 eBook, Issue 2
Pages: 22-25

What do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?

Drug development companies (sponsors) may assume a commitment to quality is inherent in the operations of every contract development and manufacturing organization (CDMO), simply because product quality is essential for ensuring patient safety. Certainly, every CDMO professes its commitment to quality. So, in evaluating potential partners to manufacture a drug or biologic, how can one accurately assess the CDMO’s commitment to quality?

The answer involves conducting a thorough on-site quality audit, asking the right questions, and requesting detailed information. The answers, data, and documents provided will reveal—by what they contain and what they omit—whether or not the CDMO has a strong quality management system and quality culture.


Read this article in the Bio/Pharma Outsourcing Innovation February 2024 eBook

About the author

Ania Szymanska is site head of Quality at Scorpius Biomanufacturing.

Article details

Pharmaceutical Technology: Bio/Pharma Outsourcing Innovation eBook
February 2024
Issue 2
Pages: 22-25


When referring to this article, please cite it as Szymanska, A. How to Evaluate a CDMO’s Commitment to Quality. Pharmaceutical Technology, Bio/Pharma Outsourcing Innovation eBook. February 2024.