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Douglas selected for FDA’s Quality Management Maturity pilot study

27/06/2024

Douglas has been selected as one of nine companies worldwide to participate in the United States Food and Drug Administration’s (FDA) Quality Management Maturity (QMM) pilot study. This selection highlights Douglas’s companywide commitment to quality and continuous improvement.

Beatrijs Van Liedekerke, General Manager of Quality at Douglas, says, “We are delighted to be one of the few companies selected to participate. The QMM program goes beyond good manufacturing practice (cGMP) requirements, which aligns with our commitment to delivering excellence at all levels of our organization.”

What is the QMM program?

A multi-agency federal task force in the United States identified that a significant cause of many drug shortages is linked to manufacturing or product quality issues 1.  Adopting mature quality management practices across pharmaceutical operations will support a more reliable drug supply chain.

The Quality Management Maturity (QMM) program will be voluntary and is designed to assist drug manufacturers in achieving higher levels of quality management maturity at their facilities. By participating, companies will be assessed on their overall quality management systems beyond cGMP requirements, and provided with improvement opportunities. The aim is to reduce the occurrence of product quality issues and improve an organization’s ability to maintain performance during unexpected supply chain disruptions.

The FDA hosted an orientation session earlier this month, and participating companies are now completing a pre-assessment questionnaire before an on-site assessment by FDA representatives takes place later this year. Companies will be evaluated against a prototype assessment protocol for assessing QMM, and will have the opportunity to provide input into the development of the QMM assessment.

Douglas's commitment to excellence

As one of the main suppliers of pharmaceutical softgel products to the United States market, Beatrijs reflects on the goals of the QMM program through a recent example: “Last year, our US out-license partner notified us of a potential market shortage of a product we manufacture, flagged by the FDA due to competitors’ supply issues. Douglas was able to promptly increase production. Our proactive response ensured continued supply to the market until a competitor resumed production nine months later. Maintaining high-quality standards and reliable supply chains is crucial to ensuring continued patient access to critical drugs.”

Participating in the QMM pilot program propels the company further in its pursuit of excellence.

Rod De Spong, Chief Operating Officer at Douglas, expresses, “We are incredibly proud to be involved in this FDA-led initiative to address the issue of drug supply shortages.  Welcoming them to our premises later this year presents an invaluable opportunity to further enhance our quality and operational practices for the benefit of our CDMO clients, partners, and end customers.”

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