An area that does not meet any of the formal pre-determined grades of cleanliness included in the Annex, i.e. grades A to D, but where a manufacturer defined level of microbial control is still required. The area should be subject to a formal cleaning/disinfection regime and formal environmental monitoring program to achieve the defined level of control. The level, type and frequency of both the cleaning program and the environmental monitoring program (including contamination limits) should be based on a formal risk assessment (captured within the wider contamination control strategy) and should be commensurate with the specific risks to the processes and product performed manufactured within each CNC area.

It is possible that different CNC areas within the same facility may have different approaches to control and monitoring, based on differing risks to processes and products.

Source: GMP Draft Annex 1


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