Ensure Compliance Excellence

Ensure Compliance Excellence: An Effective Strategy For Partnering with a Global Outsourcing Organization 

Author: Sharon Johnson, Senior Vice President, Global Quality & Regulatory Affairs, Catalent Pharma Solutions, Editor, Pharmaceutical Formulation & Quality

More than a year since Dr. Hamburg’s address to the Food and Drug Law Institute, and at a time of potential growth in outsourcing, it is timely to consider the relationship between the pharma/biotech applicant holder and its outsourcing partners with regard to cGMP compliance and the FDA 2009 enforcement policy, as well as regulatory agencies around the world. This article examines a standard way of working between the applicant holder and the pharma/biotech outsourcing company to ensure a mutually successful relationship of cGMP/policy compliance.