Quality of Pharmaceuticals and Outsourcing / Understanding the Inherent Risks to the Patient – Part 1

This article provides a comprehensive overview of outsourcing in pharmaceutical manufacturing. It discusses the motivation of the industry to leverage outsourcing advanteages, especially to China and India, but also related disadvantages. Key facts about quality issues related to outsourcing are outlined with examples. The increasing complexity of pharmaceutical manufacturing supply chains an an aggravated oversight of suppliers with the loose of control are just one explanation for that. Furthermore, the article describes how outsourcing impacts quality risks and draws on examples from the past. To mitigate these, practical advice for supplier due diligence, contractor selection and assessment process, and how to achieve operational excellence in outsourcing and internal manufacturing is drawn from a cost and risk perspective.