FDA Globalization Bill Evolving Into New GMP Legislation

As Congress continues its work on the FDA Globalization Act, a bill originally aimed at increasing FDA inspections of manufacturing facilities, the legislation is evolving into a new GMP law.

The first discussion draft of the bill, which included documentation requirements for imported drug ingredients and facility registration fees to defray the cost of overseas inspections, was released earlier this year. A second draft of the legislation was released last month by the House Energy and Commerce Committee.

The second draft would require drugmakers to manufacture pharmaceuticals under quality risk management plans and firms to conduct periodic audits to monitor suppliers. The bill also describes elements that risk management plans must contain.

“A quality risk management plan … shall address risk assessment, risk control, risk communication and risk review,” the draft states. Such plans would need to require pharmaceutical companies to use vendor qualification programs for raw materials and ingredient suppliers as well as for third-party contract manufacturers.

Quality risk management plans would have to be periodically revised and updated and would “define responsibilities and communication processes for manufacturing, quality control and quality assurance activities” for suppliers and contractors, the bill states.

In addition, risk management plans must have effective systems “to detect any hazard that has been, or is reasonably likely to be, present in or on the drug,” including appropriate specifications and test methods to verify the quality, identity, purity and strength of drug ingredients, according to the draft.

A copy of the drug-related portions of the new FDA Globalization Act draft is available at www.fdanews.
com/ext/files/Revised FDAGA Draft Drug Safety Title.pdf

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