12. August 2018

How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. In concert withthe method revamp, the agency introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

Great article by Jerry Chapman

At the FDA/Xavier PharmaLink conference at Xavier University in Cincinnati, Ohio, in March, FDA Office of Surveillance (OS) Senior Advisor Beth Philpy discussed the recent changes, why they were enacted, and the impact they will have on the pharmaceutical industry. OS is part of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ), and it is responsible for coordinating drug inspections. Both offices were created in 2015.

OS was formed by combining different functions from different parts of the agency to enable a “more comprehensive approach” to surveillance, Philpy said. Its focus is on good manufacturing practices (GMPs) and product quality. “We need to know who makes the drugs, where they are coming from, and what products are being made at what sites at any given time,” she explained.

OS is responsible for looking at approximately 7,000 human drug manufacturing sites, about 2,000 of which are medical gas manufacturers. Forty percent of the sites are domestic, and the rest foreign, including 97,000 unique products for finished dosage products and 4,000 unique active pharmaceutical ingredients (APIs), as determined by the materials’ National Drug Codes (NDCs).

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