Moving to Risk-Based Inspections - Pharmaceutical Technology

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Moving to Risk-Based Inspections
The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms and APIs of generic drugs.

Pharmaceutical Technology
Volume 36, Issue 9, pp. s30-s32

"Risk-based inspections will have a positive effect on FDA and generic-drug manufacturers," says DiLoreto. "In managing resources most efficiently, FDA will be able to focus on those manufacturers having the most difficulty in implementing and maintaining quality drug-production programs. Manufacturing facilities that have never been inspected will be considered high risk, and manufacturers with a history of active successful quality programs will be considered to be lower risk," he explains.

Carla Vozone, business development director at Hovione and industry representative of the EFCG during the negotiation process for the GDUFA, also points to the benefit of the GDUFA in "correcting the mismatch that existed in the inspection schedule and the actual supply chain." Although approximately 80% of APIs for drugs marketed in the US come from India or China, inspections of drug-manufacturing facilities in these countries are not proportional to these levels, explains Vozone. "Parity in inspections is critical to ensure safety of generic medicines," she says. She also points to the value in the provisions of the GDUFA that provide for a risk-adjusted surveillance inspections system to prioritize inspections of higher-risk facilities.

Also of significance is increased authority for FDA to deal with low-quality and counterfeit drugs. "Prior to the GDUFA, FDA had little authority to prevent low-quality and counterfeit drugs from entering the supply chain," explains DiLoreto. As of Oct. 1, 2012, FDA will have the authority to consider misbranded any drugs not produced in a registered and inspected manufacturing facility. All drugs considered misbranded may be destroyed rather that returned so they will not be allowed to enter the supply chain through different supply chain channels, he explains.

As the quality bar for generic drugs and APIs are raised under the GDUFA, the supply chain for generic drugs also may be affected, notes Vozone. "Generic-drug manufacturers will have to do a risk assessment of their supply chains," she says. Issues, such as increasing secondary sourcing or further evaluations of existing suppliers, will come into play. She also notes that the amount of the user fees, which are still being determined, will oblige producers to evaluate their cost structures for supplying a given generic API, and as a result, certain producers may exit the market for that product or the sector. These issues will be important to take into consideration in the sourcing strategies for generic-drug manufacturers.


1. FDA, "Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794," Federal Register 77 (144), 43844–43846 (2012).

2. FDA, Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (Rockville, MD), July 7, 2012,, accessed Aug. 15, 2012.

3. M. Hamburg, "Challenges and Opportunities for the Generic Drug Industry Remarks," presented at the GPhA Annual Meeting, Orlando, FL, Feb. 23, 2012.


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