An effective Contract Development and Manufacturing Organization (CDMO) partner will have the infrastructure to fulfil development and manufacturing requirements, as well as the processes to meet quality expectations. Beatrijs Van Liedekerke, General Manager of Quality at Douglas CDMO, asserts that determining whether a CDMO will meet your quality expectations involves not only assessing their processes but looking at the company culture that supports and enables them.
Assessing quality in CDMOs
Quality has crucial importance in pharmaceutical development and manufacturing. It extends beyond regulatory compliance to encompass cost and time implications associated with poor quality products. Most importantly, it directly impacts patient safety. It is no surprise that quality is a significant lever when weighing up prospective CDMO partners. Beatrijs Van Liedekerke, General Manager of Quality at Douglas CDMO, identifies three key aspects of a CDMO’s operations when it comes to assessing quality.
“Quality in pharma is non-negotiable. Determining whether a CDMO is going to be able to deliver to expectations when it comes to quality means looking at three key areas: “the processes they have in place; whether there is an organizational commitment to quality; and if they can change and adapt in a compliant way when processes don’t go according to plan.”
1. Streamlined processes for maximum productivity
Effective processes and systems play a crucial role in ensuring the quality, safety, reliability, and regulatory compliance of products and how they are made. They also support proactive quality management, allowing for the quick identification and resolution of issues that could impact product quality.
Beatrijs underscores the importance of due diligence when evaluating potential CDMO partners, emphasizing the need to thoroughly examine core Quality Management System processes such as CAPA system, change control, and deviation management. It’s important to assess whether these processes not only ensure compliance but support organizational efficiency, rather than presenting an administrative burden.
For Douglas CDMO, efficiency is prioritized through well-thought-out processes and a highly trained workforce. This approach minimizes disruptions and enhances overall performance. The implementation of an electronic quality monitoring system (EQMS) further enhances efficiency by providing visibility and ease of use for employees, as well as offering clients insight.
“The dashboards produced in the EQMS allow us to quickly monitor processes and create transparency to enable follow up. The efficiency of our well thought-through processes keeps costs low for our customers while maintaining the quality of the product and guaranteeing compliance,” Beatrijs notes.
2. An organizational commitment to quality
A strong quality culture ensures that every member of the organization prioritizes excellence in every aspect of their work. This commitment leads to higher quality products, a reduction in quality related issues, and regulatory non-compliance. The organizational culture of a CDMO plays an important role in determining their ability to meet quality expectations.
“Quality Assurance (QA) needs to be a coach and mentor, not the police. When QA has been accepted as a coach and mentor, it means there is a culture where everyone prioritizes and values quality and is motivated to achieve the desired compliance outcomes.”
“Quality is not just the responsibility of the people who have the word ‘quality’ in their job title. Every member of the organization has a responsibility towards delivering quality, including human resources to ensure the right people are hired and the right training is given.”
“Everyone at Douglas CDMO knows that quality is at the heart of what we do. And our leadership team demands a commitment to quality at every level.”
3. A proactive approach to change and adapt
Questions can be asked about a CDMO’s approach to proactively managing quality-related issues and their commitment to continuous improvement.
Once a CDMO has established its foundational processes efficiently, it can leverage data and insights to automate and manage quality processes within a closed quality management ecosystem. Transitioning from manual documentation to structured data in a relational database reflects Douglas CDMO’s dedication to continuous improvement. “While our change control, complaints and quality events currently still reside in Word documents, transitioning these to a database enhances our ability to mine data effectively together with information from CAPAs,” Beatrijs explains. “This shift reflects our commitment to evolving our practices and pursuit of excellence.”
Having a proactive approach extends to an organization’s adaptability, which is essential when addressing unexpected issues or deviations in the development or manufacturing process. “Even with robust processes, defects or accidents will happen now and again. Failure to quickly identify the root cause of the problem can result in further lost time and increased costs. Analyzing mistakes, addressing root causes, and implementing corrective actions not only prevents recurring errors but also drives continuous improvement.”
Beatrijs concludes, “Quality requires a company commitment to deliver at a high standard. Evaluating a CDMO’s ability to meet quality expectations involves looking beyond Standard Operating Procedures and basic quality processes to understand the company culture that supports and enables them. For Douglas CDMO, quality means continuous improvement, supported by a culture that expects excellence across all levels of the organization.”