Environmental monitoring is one of the systems that decide about the product quality in the manufacture of sterile medicinal products. Both European and American GMP regulations place special focus on this topic.
The USP 1116 and especially the FDA’s “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice“ deal in detail with environmental monitoring.
However, many of the requirements laid down in these documents seem to be excessive for everyday practice on the one hand and leave great scope for interpretation on the other hand.
In practice, environmental monitoring programmes sometimes develop into time-consuming, cost- and personnel-intensive measures. Therefore, it is the aim of this course to provide the participants with pragmatic recommendations for the creation and implementation of environmental monitoring programmes.
Within the framework of this course, the participants are confronted with current hot topics, like:
- Alert / action levels
- Relationship to batch release
- Locations and frequency
- Identification of isolates
- Sampling procedures
and get to know solutions for their own company practice.