Douglas continues participation in quality management program

Douglas was one of nine companies worldwide selected to participate in the United States Food and Drug Administration’s (FDA) Quality Management Maturity (QMM) pilot program.

The QMM program is a voluntary initiative by the FDA designed to strengthen the global drug supply chain through evaluation of a company’s overall quality management systems beyond current Good Manufacturing Practice (cGMP) requirements. According to the FDA’s QMM pilot program website, the program’s goals are to:

• foster a strong quality culture mindset,

• recognise establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practice,

• identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities, and to

• minimise risks to product availability to assure reliable market supply.

An in-depth, on-site review

The FDA’s assessment team observed examples of Douglas’ quality management practices and held discussions with key personnel, senior leaders, and subject matter experts over a week on-site in New Zealand, scoring five practice areas – management commitment to quality, business continuity, advanced pharmaceutical quality systems, technical excellence, and employee engagement and empowerment.

“We were very happy with the results we achieved in the QMM pilot program,” said Beatrijs Van Liedekerke, General Manager of Quality at Douglas. “It is an in-depth review of our processes and of our approach to managing processes to a high standard across the organisation, which contribute to our ability to deliver the right quality products on time.”

Innovating and improving quality controls to stay at the top

With the initial assessment complete, Douglas will continue with the pilot programme, sharing project information for ongoing evaluation. “We’re pleased to continue the pilot programme, says Beatrijs. “Douglas has opted in to this additional scrutiny as part of our commitment to high quality drug development and manufacturing. “By choosing Douglas, pharmaceutical companies gain a partner who prioritizes quality at every stage, minimising disruptions and maximising the potential for success.”