What is a Contamination Control Strategy (CCS) and what does it include?

According to the new Annex 1 (2022), a Contamination Control Strategy (CCS) must be implemented for the entire cleanroom and controlled environment system of the facility. This must define the cleanliness zone concepts with all critical control points and evaluate the effectiveness of all design, procedural, technical and organisational controls and monitoring measures used to manage the risks associated with contamination.

[GMP Compliance Adviser, Chapter 5.D]

You can find the whole new chapter 12.B on this topic here:

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