FDA's PAT Team: Shall We Dance?

FDA's PAT team aims to take compliance and manufacturing from art to science.

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TEAM OF THE YEAR AWARD FINALIST,
LARGE-SCALE PROJECTS:
FDA'S PAT TEAM



PAT (Process Analytical Technologies) is the rarest of revolutions. It needed brilliant thinkers and some prodding to get off the ground, but it is now a team-driven movement. If it succeeds, it will mean unprecedented changes for both industry and regulators.

Team leader Ajaz Hussain faced many of the same challenges -- silos and tight budgets, for instance, and lack of a quality systems approach -- that corporate manufacturing visionaries face. But, if barriers in industry are calcified, imagine them within a government agency. Getting reviewers, investigators, and compliance officers, and other staff within the Agency's different divisions together was only the first step. Then, they all had to be sold on a radically new vision for compliance.

When FDA's original PAT team was assembled in 2002, members were drawn from FDA's review, inspection and compliance sectors. Some had been with the Agency for years, others came from industry. Some knew each other, others didn't.

The team hired a consultant to help break the ice. Team members exchanged stories and got to know each other. They even danced together in one exercise. Reviewers, inspectors and compliance officers all went through the same training. At one batch manufacturing course, they even made product as a team.

Lighthearted as they may seem, these activities broke down walls between team members and built the camaraderie that has been a catalyst for the team's success.

Of course, the team's real success won't be known for another decade perhaps. But, while still a work in progress, the PAT initiative has undeniably begun a revolution within FDA, and certainly within the pharmaceutical industry, inspiring parallel movements in Europe and Asia. While PAT is just starting to make its way to the shop floor, it has created an unmistakable buzz. Change is afoot.

Not a one- or a three-man show

To date, the PAT movement has been associated with a few high-profile champions within FDA -- Ajaz Hussain, but also Ali Afnan and Chris Watts. However, the initiative was truly a team effort involving the FDA steering committee and key personnel throughout the Agency, with input from industry as well.

Each member of the PAT team had his or her hands on each and every draft revision of the PAT guidance document, ensuring that the vocabulary and phrasing suited the movement. "The final guidance document reflects a true team approach," says Chris Watts. That team now numbers nearly 30, if you include the PAT review/inspection team, steering committee, policy development team and training coordinators. More members will join the review/inspection team when a second phase of training is completed this year.

With the release of the final guidance document last fall, the group now has something to show for its efforts and rally around. Team members from top to bottom now also have the expertise and legitimacy to be effective messengers for the movement, whether spreading the PAT gospel within the Agency through a "train the trainer" approach, or in larger forums such as PAT workshops here and abroad. Using a Six Sigma analogy, Hussain says that each of the team members has essentially reached black belt status, and can now leverage this position to further the cause throughout the Agency and industry.

The PAT cadre is now a real team, says Afnan. "Our team is much more than just the sum of its members," he says. "What we're now seeing in our daily activity is uncommon interaction between us. Not a day goes by when we don't talk and communicate with several other members of the team."

"When issues come up, we actually share the burden, like different fingers of the same hand working together," Afnan adds. "We're encouraging each other to do better."

The greatest reason for the team's success, says Hussain, is its members' shared vision: to significantly improve the quality of drug products reaching the consumer. "It has been easy for everyone to buy into the values," he says. "Once we were able to articulate the mission of enhancing the quality of products getting to consumers, the apprehension melted away." Those who have been through the training see PAT as "healthy," he adds.

"In a sense, we now speak the same language," says George Pyramides, a PAT team member and chemist in the Office of Regulatory Affairs. "This language 'bridge' allows for communication between the cadre members on a level that I have not seen among other Agency teams. I now feel part of a larger group that is beyond the scope of my field laboratory."

The team is acutely conscious of the language that it uses on a daily basis and has built into its literature. It strives to stay positive and clear in all correspondence, and to re-examine and give new life to terminology that suffered from years of regulatory fatigue.

A word like "control," for instance, has long had a negative connotation synonymous with rote testing and "command and control." The PAT team probed the word for its true meaning, and redefined it, Hussain says. Now, control is a good thing, suggesting dynamic control of processes and equipment, and it is the responsibility of manufacturers rather than FDA.

The PAT team's morale is sky high. Members say they know they're part of something special. "There's a lot of excitement and enthusiasm in everything we do," says Watts.

With guidance in place and standards developed, the PAT team's greatest challenge will be maintaining the initiative's momentum. There is work yet to be done. "We're a very small part of FDA," says Hussain. "The rest of FDA still needs to come on board."

The challenge in industry is even greater, says Afnan. Already, however, FDA's PAT squad has begun to transform the Agency's, and the industry's, mindset about quality and compliance.


FDA's PAT team: Today, the Agency; tomorrow, the world (or at least U.S. pharmaceutical manufacturers) !
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