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Ensuring Complete and Efficient Process Validation Within a CMO-Sponsor Relationship

Presented at: IBC’s International Biopharmaceutical Outsourcing, Contracting, and Partnering Conference: Discovering & Enhancing Strategic Options in Biomanufacturing San Diego, CA, March 8, 2005

When companies outsource process development and manufacturing, ensuring that process validation does not fall through the cracks becomes important. Some process validation studies must be performed by the CMO while others can be performed by either the CMO or Sponsor. A process validation master plan that outlines who is responsible for what studies is an important tool for managing studies at different sites. This presentation covers strategies for coordinating and conducting process validation studies in a CMO-Sponsor relationship.