Pre-operational sanitation is the most underestimated yet decisive phase in the lifecycle of any pharmaceutical system. It represents the moment when a newly installed utility or manufacturing system transitions from being an engineered structure to becoming a GMP-relevant process element. Unlike routine cleaning, pre-operational sanitation is not about maintenance—it is about origin control. A system … Read more

The “Immune System” of Pharmaceutical Manufacturing** Imagine pharmaceutical manufacturing as a living organism—complex, sensitive, and continuously challenged by threats: deviations, failures, drifts, outliers, and non-conformities. Now imagine CAPA as the immune system of that organism—detecting harmful events, attacking the cause, and building future immunity so the same threat can never harm the system again. In … Read more