Microbiology testing in pharmaceutical development and manufacture is used for environmental monitoring, sterility testing and detection and identification of microorganisms and the applicable regulations for this work are Good Manufacturing Practice (GMP).
Currently, data integrity is a major issue in the pharmaceutical industry and citations from FDA warning letters for microbiology laboratories can be classified as:

• Failure to perform actual testing
• Falsification of data e.g. reporting failed tests as passes or modifying records

The reasons are that microbiological testing is often manual and data often relies on observation that can be manipulated, often without photographs of the plates.
 

To find out more about Data Integrity embedded in microbiology:
fill in the form to download our Whitepaper.
 

About the authors

Sandra Gay, phD
is Pharma Marketing Manager at bioMérieux.
See Sandra Linkedin Profile

Yves Samson
www.kereon.ch 
 
Automation and system engineer
He is member of GAMP Europe Steering Committees, chairman and cofounder of GAMP Francophone
 

Dr R D McDowall
www.rdmcdowall.com

Dr Robert McDowall provides management consultancy for the pharmaceutical, agrochemical and chemical industries