US FDA to take risk-based approach to biomanufacturing inspections

By Dan Stanton contact

- Last updated on GMT


Related tags: Food and drug administration

A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the US FDA says.

The final rule, to come in force on June 11 2018, revises time of inspection requirements and removes the duties of inspector requirements, both contained in section 600​ of the Code of Federal Regulations (entitled ‘Biological Products: General’).

It will affect how often the US Food and Drug Administration (FDA) is inspecting certain facilities and implement a risk-based schedule replacing, replacing the biennial inspection requirement for drug and biological product establishments required in the Federal Food Drug and Cosmetic Act (FFDCA)​ and aligning the requirements with 2012’s Food and Drug Administration Safety and Innovation Act (FDASIA)​.

“This change clarifies the FDA’s flexibility under FDASIA to inspect facilities either more or less frequently, according to the potential risk the establishment’s operations present, without diminishing public health protections,”​ the Agency said.

According to Commissioner Scott Gottlieb, the ruling is part of efforts to modernise the FDA’s regulations, remove inefficient policies and reduce costs.

“The new regulations reflect the FDA’s flexibility to prioritise its inspectional resources to higher-risk facilities, such as those that produce vaccines or gene therapies, and those that have complex manufacturing steps and must be more closely monitored due to the potential for more risk,”​ he said.

“While this means the inspection frequency for some establishments will be reduced, for some facilities it may increase.”

The ruling comes following a review of its existing regulations relating inspection requirements for biological products, and as part of President Trump’s Executive Order 13777​ issued last February intended to cut down on federal oversight by repealing two existing regulations for every new regulation.

The Agency has invited industry to comment on the changes by March 27.

Related topics: Markets & Regulations, QA/QC, Regulations

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