An Agent of Change
ISPE was founded in 1980 by a handful of people working within the pharmaceutical industry, partly as a reaction to the U.S. GMP regulation for drugs that was introduced in 1978. The idea was and remains to establish a forum where professionals from pharmaceutical and engineering companies, regulators, and suppliers could meet, share, and discuss best practices for the industry.
Today, ISPE has more than 23,000 members worldwide and 25 affiliates around the world. The global reach has made health authorities and influential pharmaceutical companies look to ISPE to face the challenges ahead in this period of change.
“As a global player, the International Society for Pharmaceutical Engineers has a unique position to play an active role in this transition, and we have therefore developed a new strategy that aims at making us an agent of change,” states Moelgaard. He stresses that ISPE is committed to help the FDA, as well as European and Japanese regulators to streamline the industry and make it more innovative. The final goal is to foster new treatments, products, and delivery systems that will cure diseases or improve life for patients around the world.
To meet this end ISPE will launch a number of initiatives under the motto Engineering Pharmaceutical Innovation. “Firstly, we have issued new documents, among which the most prominent is a standard for a new science- and risk-based commissioning and qualification practice that will enable the industry and suppliers to focus on issues that are critical to quality standards.
“Secondly, ISPE will feature a new kind of professional certification, called Certified Pharmaceutical Professional, which shall enable ISPE members to upgrade and formalize the competencies essential to the 21st century’s approach to pharmaceutical manufacturing,” says Moelgaard. The third initiative, he adds, is the launch of a new peer-reviewed journal, focusing on process analytical technology (PAT) or the science- and risk-based approach, which shall serve as a common and trustworthy source for current and innovative knowledge.
Among the new challenges that ISPE will take on, Moelgaard emphasizes the first task—installing the new risk-based and scientific approach to drug development and manufacturing among its members. “The most critical issue is the way that quality management and GMP compliance will be interpreted in the future. Basically, the change will go from the paper-intensive cookbook approach to a science- and risk-based approach, where regulators will expect manufacturers to have a scientific understanding of their product and the related manufacturing process,” says Moelgaard.
He asserts that this development has already begun and the first public visible steps soon will be taken in that direction. “The FDA has started to withdraw some of the old regulation because it is not in accordance with the regulation of the future. Also the FDA has introduced the concept of adaptive clinical trials. These are just the first significant steps in the FDA’s strategy to present new regulatory guidelines for drug approval in the future.”
In this new paradigm for pharmaceutical manufacturing in the 21st century the keywords will be ‘Risk to the Patient’— focusing and being able to control those critical product and process parameters that are important for the patients’ safety. The product quality will be scientifically ensured, and manufacturing processes will be based on a scientific understanding of its design space and control space throughout its development and manufacturing. A number of critical control points along the manufacturing process lines will be the focus of quality management when this new paradigm has been implemented.
Additionally, “ISPE can help create and facilitate changes through education, courses, communities of practice, professional certification, and our local chapters and affiliates. Because ISPE is both local and global, our events and guidelines can be used by both small and large international companies as a way to ensure a uniform education of their employees all around the world.”