Environmental Monitoring Data Management – from Collecting to Trending
: 20 Nov 2019 - 21 Nov 2019
: Barcelona, Spain
Regulatory agencies require that manufacturers of pharmaceuticals and biopharmaceuticals, particularly of sterile drug products, maintain an environmental monitoring program, whereby particulates, as well as microorganisms in either air samples (active and passive sampling) or on surfaces (contact plates), are routinely tested and monitored.
Thus, a multitude of environmental microbial data is generated, on a routine basis, and it is recorded in a manner permitting trend evaluation. But collecting EM data is only the first challenge. The next challenge for the responsible person in quality is charting, analysing data, setting action and alert limits, interpreting the overall monitoring process behavior, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis.
According to the recent revision of EU Annex 1 (Dec. 2017), results from monitoring should be considered when reviewing batch documentation for finished product 1638 release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.
Delegates will learn:
- An overview of controlled rooms classifications, elements of an EM program and present EU and FDA regulations including the recent ISO 14664 changes.
- How to organize and present an abundant amount of microbial data in meaningful graphs
- How to draw useful control charts with this data, using the software program MinitabR18
- How action and alert control limits are set
- How to demonstrate that the environmental microbial monitoring process is under a state of control
- How to calculate and plot the newly proposed contamination recovery rates in USP Chapter <1116>
- To detect a trend in the environmental microbial monitoring process
- How to apply risk assessment in investigations