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FDA wants pharma to move from compliance to quality

By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.

By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.
By establishing an Office of Pharmaceutical Quality, FDA hopes to spur pharmaceutical manufacturers to address batch process, packaging, and other problems impacting the supply chain.

Has a focus on regulatory compliance caused drug makers to lose sight of quality? An FDA expert shared his agency’s concerns and requests at the 5th-annual PharmaLink conference at Xavier University in Cincinnati in March.

Ten years ago the FDA created “A Vision for 21st Century Manufacturing.”  FDA wanted an efficient, flexible pharmaceutical manufacturing sector producing high-quality drugs without extensive regulatory oversight. Today, FDA is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic, and over-the-counter drugs, and is calling on industry to offer up metrics to prioritize field investigations, said Russell Wesdyk, Scientific Coordinator for FDA’s Office of Pharmaceutical Science.

Wesdyk has more than 25 years experience and is now working with generic, biotech, and branded segments within the Center for Drug Evaluation and Research (CDER). His conference presentation, “FDA/CDER’s evolving approach to quality and the use for metrics” set the tone for the two-day event. Wesdyk also was open and gracious when fielding all comments and criticisms the Xavier crowd could offer up.

According to Wesdyk, there has been a tremendous increase in field alert reports, recalls have increased dramatically, and drug shortages due to component problems, delays, and capacity issues (quality) are increasing as well.

Industry itself is ultimately responsible for quality, of course. But while some plants are improving facilities, modernizing control platforms and process technologies, and rolling out quality-by-design (QbD) programs, the facts do not support the idea that there has been real improvement.

“Alerts, recalls, and shortage data do not bare out that we are making progress yet—despite what drug makers say about improvements in quality,” said Wesdyk.

Industry’s position, according to Wesdyk, is “all the FDA cares about is compliance to GMPs [good manufacturing practices]. You don't care about quality.” GMPs do matter and, at least in theory, quality is covered in the GMPs, he said. But the agency is thinking that compliance may have become such a focus that drug makers are not sufficiently concentrating on quality—quality of the process, the batch, the packaging, and the distribution. This lack of focus on quality has resulted in recalls, drug shortages, and other impacts on consumers.

“Take a cancer patient on a pretty special drug,” said Wesdyk. “The plant is registering 50 percent of batches failing. Does that sound like a validated process to you? [When that many batches are failing,] you start running into availability issues. But a Form 483 is not going to get that drug in the patient’s hands any faster.” 

Form FDA 483 is used by the FDA to document and communicate concerns discovered during inspections. It includes “inspectional observations [that] do not represent a final agency determination regarding your compliance.” A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement, and either providing a timeline for correction or requesting clarification of what the FDA requires.

Compliance with the 483 process is separate from investigating and rectifying the cause of the batch failure, and does not address quality per se. Indeed, a “quality culture” may be the “soft metric” needed to separate the good plant from the problematic, Wesdyk said.

Prioritizing resources

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