The QMN Weekly Bulletin

FDA’s OPQ Emerging Tech Program Plans to Help Sponsors Avoid Manufacturing Quality Failures

June 23, 2017

The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation.

Two-thirds of drug shortages resulted from product-specific quality failures or general manufacturing quality issues, said Lucinda Buhse, director of the Office of Testing and Research in CDER’s Office of Pharmaceutical Quality. Product recalls have also surged in recent years, Buhse said, during the DIA’s annual meeting in Chicago this week.

In addition, the OPQ program can help facilitate new clinical advances by developing the expertise to approve a wider range of novel doses, formulations and combinations — a necessity as treatments begin to trend toward personalized medicine and therapies tailored for individual patients, she said.

Overall, the program serves as a central location for agency and sponsor inquiries on novel technologies and is aiming to serve as an industry partner, with goals of improving manufacturing efficiency, lowering costs and increasing supply chain flexibility.

Sponsors accepted into the program are allowed early engagement with the emerging technology team, including site visits, if needed, ahead of official inspections.

“For a lot of emerging technologies, it’s hard to explain it on paper,” said Buhse. “You really need to see it.” The program also liaises with the Office of Regulatory Affairs, so investigators can become more familiar with the technology, with the goal of maintaining the same team throughout the review process.

Since its launch in 2014, the program has accepted 32 requests, including technologies such as 3D printing for drug products, and switching from a batch system to continuous manufacturing for an already approved medication.

Sponsors do not need to be submitting a new drug to consider applying for the approval of new manufacturing technologies, Buhse said. Other examples include closed aseptic filling processes, as well as novel containers and closures.

The OPQ’s laboratories house several pieces of continuous manufacturing technology, which are used to train reviewers in the process, Buhse said, including continuous crystallization equipment, a perfusion bioreactor used in bioprocessing,  hot melt extrusion equipment and twin-screw wet granulation hardware.

Also this week, Commissioner Scott Gottlieb described to Senate appropriators how the FDA’s medical innovation development plans aim to modernize review policies to keep pace with advancements in the industry.

The program plans to produce new guidance for the development of targeted drugs and clinical trials within the next six months, Gottlieb said while testifying before Senate appropriators.

The FDA also opened a docket seeking industry comments on proposed best practices for continuous manufacturing. According to a notice in the Federal Register, the agency is seeking information on control strategy, facility and process validation considerations for continuous manufacturing of solid oral medications.

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