Manufacturing and quality

Sterile manufacture and contamination control

Contamination prevention combines facility and process design, operating procedures and monitoring. Annex 1 states that monitoring or testing alone cannot assure sterility.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Sterile products; applying selected principles to non-sterile manufacture needs documented justification.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Map contamination risks to process steps and interventions.
Identify prevention measures before relying on monitoring.
Review qualification, validation and applicable aseptic process simulation evidence.
Connect monitoring trends to investigations and strategy review.

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Sterile manufacture and contamination control

Prepare your evidence before a decision

Continue to practice