How to Evaluate a CDMO’s Commitment to Quality

Published on: 
BioPharm International, Partnerships for Outsourcing, May 2024 eBook, Volume 2024 eBook, Issue 2
Pages: 12-16

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?

Partnerships for Outsourcing eBook May 2024

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.

Act like an FDA inspector

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A CDMO should welcome an on-site audit of its facilities and operations as part of the vetting process. Reluctance to have an audit is a red flag that something is wrong.

If the sponsor company is a small start-up or has limited auditing experience, an experienced firm may be hired to conduct the inspection, ideally with the participation of a member of the sponsor’s own team.

If the sponsor conducts the inspection, a great way to ensure all the bases are covered is to follow the FDA quality system inspection technique that the agency publishes for use by its own inspectors (1). The FDA guide describes how inspections should be performed on six systems—those related to quality, facilities and equipment, materials, production, packaging and labeling, and laboratory controls. The approach described should be adopted, and the following key questions should be asked and certain information requested.

Read the article in the Partnerships for Outsourcing eBook.

Article details

BioPharm International®
Partnerships for Outsourcing eBook
May 2024
Pages: 12-16

Citation

When referring to this article, please cite it as Szymanska, A. How to Evaluate a CDMO's Commitment to Quality. BioPharm International Partnerships for Outsourcing eBook, May 2024.