NIH provides interim corrective action plan for sterile facilities

The USA’s National Institutes of Health has submitted interim corrective action plans to the Food and Drug Administration 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.

As part of the plan, the 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.

The 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.