The importance of the contamination control strategy (CCS) in relation to Annex 1

The concept of CCS – Contamination Control Strategy is defined in the Annex 1 glossary (not present in the previous version) as: 

A planned set of controls for microorganisms, endotoxins/pyrogens, and particles, derived from the current understanding of the product and the process, ensuring both process performance and product quality. The controls may include parameters and attributes related to the active substance, excipients, materials and components of the pharmaceutical product, operational conditions of the plant and equipment, in-process controls, finished product specifications, and related methods and frequencies of monitoring and control.