Editorial discusses contamination control strategies in drug manufacturing, highlighting digitalization's role and the EU GMP Annex 1's implications.
Contamination control has moved from the sidelines to the spotlight in the pharmaceutical industry. As sterile drug manufacturing faces mounting regulatory expectations and rising product complexities, the call for zero tolerance towards contamination is louder than ever. The past few years have brought a transformational shift, driven by two major forces—acceleration of digitalization and the long-anticipated EU GMP Annex 1 revision. Together, these forces are reshaping how sterile manufacturers understand, mitigate, and monitor contamination risks. This article explores how digitalization is powering this shift and why the new Annex 1 is more than a compliance update—it’s a strategic playbook for building proactive, predictive quality systems.
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Rajasekhar Gollapinni (2025) studied this question.
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