For aseptically manufactured medicinal products, the result of the sterility test is an essential criterion for the release of a product batch for the market. As part of quality control, the test must be assigned to the manufacturing process, which results in the regulatory requirement for integration into a contamination control strategy in accordance with Annex 1 of the EU GMP guidelines. One way of achieving this in a scientifically sound and practicable manner is to present it in the form of a risk assessment, from which critical control points for the CCS can then be derived.