Microbiological Testing in GMP

Short description
Objectives
Target group
Program
Questions?

Microorganisms are part of our lives. But when they appear in the wrong place at the wrong time, they are the subject of broad discussion: especially in the pharmaceutical industry! This training addresses a variety of microbiological tests.

Duration: 2 days
Course fee: € 1700 (excl. VAT)

Short description

This course is only available for group registrations of 6 trainees or more. Please contact us at info@biotechtrainingfacility.nl to arrange a date.

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.

Objectives

Learn what the most relevant microbiological tests are and their critical aspects to the (production) process in GMP environments.
Learn why these tests are important for patient safety.
Learn to interpret microbiological results to be able to conduct first-rate investigations even when anomalies occur.

Target group

To whom do we recommend the Microbiological Testing course?

Microbiological analists/technicians/lab staff, quality assurance, quality control staff, teamleaders, managers, and postdocs looking into the connection between science and the application of microbiological testing.

More generally, anyone who wants to understand the relationship between microbiological testing and the GMP processes within the pharmaceutical industry.

Kyanie Behchet (Biotech Training Facility)

Trainer
Nancy de Jong (Biotech Training Facility)

Trainer
Nilbeste Boncukcu

Trainer

Program

Day 1

	Welcome and introduction
	Theory • How do microorganisms grow in the laboratory and how do they grow in products and processes • Explanation of microbial enumeration methods (bioburden quantification, calculation of CFU’s) • Read out, interpret and calculate bioburden results in raw materials, water and product samples • Microbiological identification techniques, establishment of house-flora
	Practice • Colony-forming unit (CFU) tests • Growth promotion testing of microbial media
	Closure

Day 2

	Welcome and introduction
	Theory • Sterility testing • Validation of the colony-forming unit (CFU) quantification and the sterility testing • Endotoxin tests, taking samples, sample storage
	Practice • Sterility testing • Validation of the colony-forming unit (CFU) quantification and the sterility testing • Endotoxin tests • Interpretation of results, how to handle abnormalities • Practical examples
	Closure