JVT Journal Articles
Vol. 14, Issue 4, Nov 2008

This article provides a description of a method for assessing risk to product quality during the development, manufacture, and processing of pharmaceutical and biological products. There are a number of possible methods of assessing risk, as described in ICH Q9 Quality Risk Management (1). This article presents a two-phase approach to risk...
Cell culture is the process by which mammalian cells (e.g., human, animal, or insect) are grown under controlled conditions The most commonly used mammalian cell lines are Chinese hamster ovary (CHO), mouse myeloma (NSO), and human embryonic kidney (HEK-293) Cell cultures consist of either suspended or adherent cells Protein is produced within...
The purpose of quality control evaluation is to determine, with a high statistical confidence, whether or not the process mean or variability have changed All processes should be designed to produce a desired target value The choice of equipment, materials, methods, and training defines the predictable range of process variability Process...
Pharmaceutical solids may be crystals, crystal solvates or hydrates, crystal desolvated solvates or dehydrated hydrates, or amorphous solids All crystal forms described can exist in different forms called polymorphs Polymorphs can have significant differences in their physical properties even though they are chemically identical. Physical...
Validation is a critical tool to assure quality in a manufactured product Validation as a quality system that must be treated with the same degree of planning and organization as other quality systems such as training and document control The validation master plan (VMP) is the fundamental document that defines the validation quality system A...
David E. Jones
,
David W. Vincent
,
Paul L. Pluta, Ph.D.
,
Timothy J. Fields
Recent articles and discussions have emphasized the expectations for a comprehensive and integrated approach to the validation of manufacturing processes—the lifecycle approach to process validation.
Part I of this series discusses the application of quality by design (QbD) to the development of cleaning cycles (1). An important element of QbD is cleaning characterization at small scale. The small-scale data can be used to predict cleaning times at full scale. The data can also be leveraged to streamline validation requirements for...
This article summarizes useful approaches used to reduce validation effort and lessons learned in the process of delivering a project. A case study is presented illustrating the execution and delivery of validation projects. The aim of every pharmaceutical company today is to deliver a drug to the market as fast as possible without risk to the...
Incorporating acceptance sampling into validation studies enhances their credibility through the use of confidence statements. Unfortunately, validation reports often fail to include confidence statements and their justifications. Such reports may instead rely on the successful completion of as few as three test runs. Because confidence...