Integrating Good Manufacturing Practices During the Transition From Clinical Trials to Commercial Manufacturing

April 1, 2011

Our experience shows that early adoption of GMP (Good Manufacturing Practices) by a company, can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, in-house or out-sourced. The interpretation of compliance regulations, and subsequent recommendations in this document, are a compilation of years of experience and best practices from leading bio/pharmaceutical companies.

This whitepaper was developed to broaden the knowledge of regulatory issues as they relate to bio/pharmaceutical and API clinical trials and manufacturing.  It discusses the importance of early adoption of GMP and use of technology to simplify compliance.

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