From GE Analytical Instruments
A leading pharmaceutical manufacturer with high
production demands faced cleaning validation challenges.
This company's mature, validated production facility
was expanding the amount of products they planned
to produce. This expansion was going to require the use
of non-dedicated equipment and different formulations.
But instead of validating multiple product or compound
specific methods for cleaning validation, the company
decided to utilize industry accepted, non-specific methods
that would provide a more accurate picture of the overall
cleaning process.
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Topics of Interest
The use of total organic carbon (TOC) in cleaning validation has become a widespread best practice throughout the pharmaceutical industry as an analytical method designed to verify the performance of...
Interest in Total Organic Carbon (TOC) analysis as a non-specific method for cleaning validation has grown considerably during the past decades because specific analytical testing, like High...
In order to more easily understand the information presented in this chapter, it may be helpful for the reader to consider the activities that are involved with making, operating, and maintaining a...
It is essential to any cleaning validation program that analytical methods are selected appropriately for their intended use. Analytical methods should be able to adequately determine that a validated...
Even the best-designed, mature database occasionally requires some type of data validation. Although most data validation problems can be eliminated on the "front end" during data entry and loading,...
