FDA cGMP initiative: A streamlining step in the right direction

By Mark A. DeSorbo

WASHINGTON, DC—IT WAS ONLY IN the last.25 years that two college dropouts founded Apple Computer in a garage, while Wang was building word processors linked to central computers for office use.

At the same time, lung cancer had risen to the second-most common cancer among women, the world's first test-tube baby, Louise Brown, was born in London while the world's last-known case of smallpox appeared in Somalia—the troublesome disease was considered eradicated when it re-appeared in 1979.

The late 70s and early 80s was also right around the last time the U.S. FDA significantly revamped its current good manufacturing practices (cGMPs), a medical industry protocol that is once again under the agency microscope.

And according to a Quick Vote poll on www.cleanrooms.com, 45 percent of the respondents said it's about time the FDA align its regulations with the times, while another 45 percent believe the FDA's initiative to revamp cGMPs is a gamble. The remaining 10 percent say the effort is a complete waste of time.

John Hodges, marketing manager for high-purity chemical distributor Doe & Ingalls (Durham, NC), liked what he read in the first 10 pages of the 33-page initiative concept paper.

“Our warehouse meets all kinds of cGMPs, and that's a big selling point for us,” Hodges says. “It seems like it wilhelp streamline the process, which would be good. Whether there is any substance to it remains to be seen. Government regulations are so subject to interpretation. There are a lot of gray areas, but any step that will streamline it is a step in the right direction.”

Francis McAteer, vice president of Microbiology Associates Inc., an Acton, MA-based lab that offers customized testing services, agrees, saying a cGMP overhaul is “a good thing.”

“The last major change was 25 years ago, there have been a lot of changes since then, and the technology continues to change,” says McAteer. “It sounds like they are going to make some changes to be more industry-friendly in response to some of the new technology. With all the advances in tissue engineering and genomics, the old rules—the old FDA template—does not apply.”

The initiative will cover veterinary and human drugs, including human biological drug products such as vaccines. This initiative, according to the agency, is designed to improve public health promotion and protection by focusing on three major goals that will augment FDA's pharmaceutical product quality assurance programs across the board.

The three major goals are:

  • To enhance the focus of the agency's cGMP requirements squarely on potential public health risks by providing additional regulatory attention and agency resources to those aspects of manufacturing that pose the greatest potential hazards.
  • To ensure that FDA's essential work in establishing and enforcing pharmaceutical product quality standards does not impede innovation and the introduction of new manufacturing technologies in the pharmaceutical industry.
  • To bolster the consistency and predictability of FDA's approach to assuring production quality and safety among the FDA's centers and field components.

Along with the major goals, there are numerous short- and long-term objectives, and the FDA will actively solicit participation and input from end-users, manufacturing quality control experts, academia, and government and consumer groups.

While the question was only posted for a few days at press time, 83 percent of those responding to another cleanrooms.com Quick Vote said they would participate in public forums on the FDA initiative.

Russell E. Madsen, acting president of the Parenteral Drug Association (PDA), a Bethesda, MD-based international association for pharmaceutical science and technology, says the organization is committed to working with the FDA to ensure “the enhanced regulations are meaningful, science-based, and effective in protecting the public health, while allowing manufacturers the flexibility to adopt new production technologies and fully-integrated quality systems designed to further improve the unsurpassed pharmaceutical quality and safety we currently enjoy in the United States.”

Other organizations, like the International Society of Pharmaceutical Engineering (ISPE; Tampa, FL) are more reserved about the initiative, saying it does not represent companies or lobby and would therefore have nearly as many reactions to the FDA efforts as its membership numbers.

“Our members are likely to be the ones most significantly impacted by the FDA's initiative,” says Bob Best, president and chief executive of ISPE. “While there were not many specifics contained in the FDA announcement, ISPE is receptive to developments that will lead to safer and more efficient methods of production. We are in a position to work with constituencies to develop the details enabled by this new initiative, then, just as importantly, to train those same constituencies.”

For more information on Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, visit www.fda.gov/oc/guidance/gmp.html.


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