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FDA Takes First Step in Updating Manufacturing Rules

Donna Young

Endeavoring to reduce the number of drug product recalls while safely keeping products on the market to prevent shortages, the Food and Drug Administration (FDA) is undertaking a risk-based approach to the current good manufacturing practices (cGMP) for pharmaceuticals.

FDA released a six-month progress report yesterday highlighting completion of the first stage of the agency’s plan, which was announced last August, to modernize the regulations governing safe pharmaceutical manufacturing and product quality.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), said FDA’s risk-based approach will encourage the kind of manufacturing practices that will decrease drug recalls and help drug makers "get it right the first time."

Woodcock is leading the steering committee overseeing the two-year initiative.

"Availability of drug products," she said, "is a very important part of our goal. Our goal is to prevent regulatory problems that lead to shortages."

As part of the initiative, FDA has proposed new processes for resolving disputes between the agency and pharmaceutical companies. One such process is the promotion of prompt discussions of questions and issues raised during an inspection to resolve problems quickly.

A key element of the initiative, Woodcock said, is to increase the training level of FDA inspectors and create a group that will specialize in inspections of drug-manufacturing sites. This change will allow the agency to focus its resources on inspecting the manufacture of certain types of pharmaceuticals, including sterile drug products.

FDA’s inspectors, she noted, have educational backgrounds in science and are usually trained by the agency in general inspection processes that do not focus on any particular specialized field.

Inspectors generally work with all of the agency’s divisions, including food safety. However, under the new training program, Woodcock said, the specialized group of inspectors will have a closer working relationship with CDER officials.

FDA has recently added inspectors with backgrounds in chemical engineering and industrial pharmacy, she added, but the agency has not increased its total number of inspectors.

She estimated that the agency has "several hundred" inspectors, but she could not provide a specific count.

FDA released a draft guidance document yesterday to clarify the scope and application of regulations on electronic submission and record-keeping requirements while the agency considers whether to revise those regulations. The agency also released a draft guidance document on comparability protocols that will allow for certain types of manufacturing changes—particularly advances in manufacturing technology—without prior submission and approval of a supplement to the new drug application.

Additionally, the agency is launching a program to identify and address the inconsistencies that pharmaceutical firms have noted in cGMP-related warning letters.

FDA will host a workshop April 22–24 to solicit public input on scientific aspects of the initiative.