Innovations of Annex 1 and the CCS

– Understand the importance of the CCS for product and process safety
– Experience the practical implementation of the CCS in pharmaceutical environments according to new standards

The Annex 1 of the EU GMP Guide for the manufacture of sterile products has been applicable since 2023. A key innovation is the contamination control strategy, also known as the Contamination Control Strategy (CCS). This strategy runs through all chapters of the revised Annex 1 and is already being evaluated by inspectors in Switzerland. It encompasses planning, manufacturing, water production, packaging, storage, and transportation, requiring consistent implementation across all areas of production.

Stay informed and prepare optimally for the new Annex 1 to effectively implement the CCS in your operation.