Quality management during manufacturing changes: part I

Published: 10-Sep-2025

Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards

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Amidst continued supply chain complexities, manufacturing consolidations and company acquisitions and divestments that are reshaping the competitive landscape, business executives are being pushed to enact product and process adjustments as quickly as possible to reduce expenses, retain market share and drive innovation with predictable market access timelines.

Quality management during manufacturing changes: part I

Although well-intended, sustained pressure to expedite company change programmes can create significant blind spots that sacrifice process and product controls, thereby adversely impacting business continuity, product quality and patient safety.

This analysis explores why simultaneous manufacturing changes can create significant risks and shows how detailed change control programmes provide the antidote needed to mitigate these problems.

Mike King, Senior Director of Product and Marketing, and Gregg Sherman, Principal, Quality and Compliance Consulting, from IQVIA, report. 

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