GXP Journal Articles
Vol. 21, Issue 4, Jul 2017

This month's issue of Journal of GXP Compliance is sponsored by Waters Corporation, a company that has pioneered a connected portfolio of separation and analytical science, laboratory informatics, and mass spectrometry, Waters’ technology breakthroughs and laboratory solutions provide an enduring platform for customer success.
Tim Sandle
To meet regulatory expectations, the role of the microbiologist is essential. This issue's introduction by Tim Sandle reviews concerns and topics faced by pharmaceutical microbiologists.
Tim Sandle
This paper discusses the key criteria for autoclave cycle development; the use of a matrix approach for qualifying an autoclave and the key parameters (thermometric and biological) for evaluating the success of the validation.
Jeanne Moldenhauer
For many companies, there have been questions on why an in-house library is necessary and how to set up this library of isolates. This paper describes the basis for needing this type of library as well as a way to establish this type of library.
Tim Sandle
This article addresses these points and provides a basis of the microbiologist in each pharmaceutical or healthcare organization to develop a microbial identification strategy.
Jeanne Moldenhauer
Since the early 1990’s there has been an increased emphasis on the need for environmental monitoring by many different regulatory agencies. Learn what a total environmental monitoring program is to see where yours can improve.
Jeanne Moldenhauer
Many individuals come into contact with airborne mold on a daily basis. In some facilities, employees travel between buildings on a campus going through the environment and are exposed to airborne contaminants.