Contamination control strategy formally documented

The controls themselves largely existed already — facility design, utilities, personnel flow, material transfer, disinfection, environmental monitoring, preventive maintenance. What the strategy adds is the connection between them: a single document that states, for each identified contamination risk, which controls address it and how their effectiveness is judged.

“Every control was already there. What was missing was the sentence connecting them.”

Writing it exposed the gaps that individually documented controls conceal. Two controls can each be adequate while the handover between them is not, and it is at those seams that the strategy did most of its work.

The strategy is reviewed periodically and after any change that affects the classified areas, and it is the reference document for contamination-related risk assessments.