Microbiological Testing in GMP

What can you expect from the Training Course on Microbiological Testing?

The presence of microorganisms affects the quality of the pharmaceutical product. Because of the different microbiological parameters within a pharmaceutical facility (air quality, surface, water, product control), it is important to realize the relationship between the tests performed in a microbiological laboratory and the quality of the production process. 

This course focuses on understanding the relation between microbiological quality control of production areas, raw materials, intermediates and end products, in a pharmaceutical environment in the broadest sense.

Growth promotion testing, environmental monitoring, sterility testing, bioburden, and endotoxin testing. What do their results really mean? How are these methods executed and validated?What does a microbiological “Out of Specification” mean for the production process?  

Participants of this course are going to answer these questions using a mix of theory and practical training. Upon completion of this course, participants will be able to correctly interpret microbiological results within the context of GMP and patient safety.