
NIH Outlines Corrective Action for Sterile Manufacturing Facility
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
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
NIH released a separate plan to address issues in the
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.