The Journal of Validation Technology
Vol. 14, Issue 1, Feb 2008

Gamal Amer, Ph.D.
The equipment, facility, and utilities for the manufacturing, processing, packaging, or holding of a drug product or medical device must be qualified/validated to meet current good manufacturing practice (CGMP) requirements. Thereafter, manufacturing processes conducted in the facility and utilizing the equipment and utilities are validated....
Pramote Cholayudth
J. S. Bergum recently introduced his new method for computing the probability of passing the new ICH USP 29 Content Uniformity Test in a paper entitled “Acceptance Limits for the New ICH USP 29 Content-Uniformity Test,” in the October 2007 issue of Pharmaceutical Technology (1). The probability, when computed using a given content uniformity data...
Validation professionals often allocate extensive amounts of time to thermal validation.
A variability reduction project was implemented in a pharmaceutical analytical development laboratory. This variability reduction project was implemented in response to an unexpected result seen in the yield chart for a production process within development. The approach was simple and quick to implement. The results were profound. For one in-...
Recent documents and discussions have emphasized a comprehensive and integrated approach to the validation of manufacturing processes—the lifecycle approach to process validation.
Jerry Lanese
"Three Times is not Even the Beginning" by Jerry Lanese, Ph.D., was originally published in the Journal of Validation Technology in early 2001. This paper was greatly influenced by the thoughts and writings of Ken Chapman. The philosophy and content of this 2001 paper are still valid today. Dr. Lanese's examples and discussion...
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