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Article / Jan 01, 2006

EU To Begin ICH Q7A Enforcement

“The Gold Sheet”, Vol. 40, No. 1, January 2006

NEW EU REQUIREMENTS FOR API GMP OVERSIGHT are now in force calling for finished product manufacturers to audit their bulk suppliers and attest to their GMP compliance. With global implications, European regulators and industry have been debating how to create an effective implementation approach, and a flurry of guidances and position papers is emerging. The EU industry views authority inspections as a critical enforcement lever in the effort to achieve fairer competition with Asia and more control over API quality. [A detailed explanation by a European regulatory official of the new API GMP legislation and implementing measures and the impact on the obligations of application holders, API manufacturers, and regulatory authorities is provided on pp. 19-23. A recent release from the EMEA focusing specifically on the expectations for API auditing by dosage manufacturers is included on pp.3-4.] 

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