NIH Plan Addresses Sterile Manufacturing Deficiencies

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

As part of the plan, NIH will hire a contracting firm experienced in CGMP regulations and procedures to provide an evaluation of the PDS operations and make recommendations for improvement and to address 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 16-page PDS plan addresses observations identified on a Form 483 issued by FDA on May 29. The plan outlines a timeline to achieve key milestones including retaining a GMP consulting firm by June 24, 2015; developing a corrective action plan by Aug. 14, 2015, dependent on consulting firm deliverable; training or retraining personnel with GMP-specific training courses by Aug. 14, 2015; and developing standard operating procedures by Sept. 1, 2015.

NIH released a separate plan to address issues in the pharmacy area.

Source: National Institutes of Health