Good environmental monitoring is mandatory in the pharmaceutical industry and the data generated is highly relevant. Calibration and qualification data are considered separately from routine monitoring data. The latter are proof that the framework conditions defined in the qualification process are also adhered to during operation and that the data is consistent over a longer period of time.

Particularly critical values come from the microbial monitoring of the ongoing production of sterile products (terminally sterilized and aseptic products). In the past, many pharmaceutical companies carried out "spot checks" from the beginning to the end of filling. This is no longer acceptable. Based on the new Annex 1, the health authorities require practicable, continuous monitoring during all filling phases in Class A areas.
Annex 1 thus paves the way for alternative monitoring systems, the use of which must, however, be appropriately justified and scientifically recognized.