How to Evaluate a CDMO’s Commitment to Quality
News
Article
BioPharm InternationalPartnerships 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?
medicine science factory staff worker check quality products sterilize in autoclave tank in check list. | Image Credit: ©Quality Stock Arts - stock.adobe.com
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.
Act like an FDA inspector
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.
Recent Videos
Related Content
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Podcast
Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance (May 2025)
May 16th 2025Article
Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.
Mastering Antibody-Drug Conjugates
December 19th 2024Podcast
In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Optimizing cGMP Facility Design Space with a Hybrid Approach (May 2025)
May 16th 2025Article
In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.
