NIH Submits Corrective Plan for Sterile Mfg Deficiences

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-22-2015 11:48


The National Institutes of Health (NIH) has submitted interim corrective action plans to the US Food and Drug Administration (FDA) to address problems with sterile manufacturing processes identified in its Pharmaceutical Development Section (PDS) and deficiencies of lesser significance in its pharmacy announced on June 4, 2015.

"NIH takes this issue very seriously and senior leadership took swift action to ensure the safety of research participants," said the NIH in a statement. "As corrective action is taken to remedy the situation, NIH will continue to take every measure to protect patients and provide access to needed treatments.

As part of the plan, NIH will hire a contracting firm experienced in current good manufacturing practice (cGMP) regulations and procedures. The firm will provide a full evaluation of the PDS operations and make recommendations for improvement and for addressing all FDA concerns. NIH will also establish an external group of advisors with expertise in cGMP-facility management, clinical research, engineering, and regulatory requirements to consider the recommendations of the contractor and oversee the implementation of the corrective actions. The plan outlines an aggressive timeline to achieve key milestones by the end of September 2015.

The full corrective plan for PDS may be found here.

Source: NIH


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