The presentation covers the current requirements of EU GMP Directive Annex 1 and its impact on sterile production processes. The focus is on the correct qualification of cleanrooms in accordance with ISO 14644, including particle counting, differential pressure monitoring, filter integrity testing, and microbiological monitoring. In addition, the implementation of a contamination control strategy (CCS) and the integration of quality risk management (QRM) will be explained. Practical examples show how companies identify risks, set limit values, and carry out regular reviews. The presentation covers both regulatory basics and specific recommendations for validation, documentation, and audit preparation to ensure compliance and product safety.