September 1, 2006 (Vol. 26, No. 15)

Society Makes Changes to Comply with Revised Risk-based GMP Paradigm

The pharmaceutical industry is at the beginning of a transition period in which major technological changes may significantly affect the industry, according to Gert Moelgaard, chairman of the International Society for Pharmaceutical Engineers (ISPE) and vp at NNE ( “Looking 10 years ahead, I believe you may find a very different pharmaceutical industry. The significant changes that we are starting to see worldwide might very well just be the prelude to a greater transformation.”

Possibly, the transformation could end up being just as significant as seen in, for example, the electronic industry, when the transistor replaced the vacuum tube, predicts Moelgaard. “Suddenly, the existing technology was no longer the solution of the future, and large and respected companies disappeared because they were not up-to-date.”

Moelgaard points to recent developments, like the FDA’s Critical Path Initiative, to achieve affordable drugs and restore innovation in the pharmaceutical industry, but also to the big drive toward biopharmaceutical drugs and personalized drugs as factors that will affect pharmaceutical companies worldwide. “Drug development today is extremely expensive, and traditional drugs must have blockbuster potential in order to make it through the pipeline of discovery, development, and manufacturing and reach the market and the patients—some of whom have diseases that they have almost given up hope for finding a treatment.”

The traditional drug development paradigm has failed to consider the risk imposed on patients when new drugs aren’t being developed because of a regulatory and development regime that hinders innovation, stresses Moelgaard. “Fewer new and innovative drugs are being developed, and regulators in U.S., Europe, and Japan fear that the pharmaceutical industry has lost its ability to innovate.

“Luckily, regulators and governments around the world have realized the dilemma and the need to think in both risk and benefit to the patients when developing new drugs. They have therefore taken initiatives to change the situation, and ISPE is now working with them across all significant regions of the world to help reach this goal.”

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.”

Coherence in a Period of Transition

Moelgaard believes that this development means that the pharmaceutical engineer of the past is a very different creature than the pharmaceutical engineer of the future. “ISPE is at a turning point right now. We need to keep supporting those that continue within the current paradigm, while we will actively go ahead with the necessary changes to comply with the new risk-based GMP paradigm. There will still be work for the traditional engineering disciplines, but product and process understanding will become increasingly important competences. This development presents ISPE with the challenge of becoming an agent of change while still sticking to those values which today make people join ISPE.”

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