Strategies for Ensuring Regulatory and cGMP Compliance of Outsourced Stability Programs

Chapter
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)

Abstract

The process of outsourcing requires continuous improvement and open communication. In this article, the author examines the stages of outsourcing, beginning with the decision to outsource and select the vendor. Following the topic of choosing the vendor, the article describes the startup phase and offers advice on how to monitor the ongoing studies and manage change during an ongoing stability study or a development program. During the management-of-change phase, the author illustrates relevant, real-life examples from her career of what to avoid during the management of stability studies. The article concludes with the topic of continuous improvement.

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Vertex Pharmaceuticals Co.CambridgeUSA

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