JVT Journal Articles
Vol. 14, Issue 3, Sep 2008

This paper proposes an automated digital system for the selection of the most cost-friendly process validation sampling plan. The system is based on the US Food and Drug Administration’s mandates and other standardized procedures. The algorithm is designed to deliver one output as a function of multiple input parameters with-out further interaction with the users. The system will reduce any possible subjective elections and...
Company X has engaged the services of a contract manufacturer to process their pharmaceutical product through manufacture, packaging, and labeling of the final dosage form. Company X has been using this contractor to make this product for seven years.
Few would argue that the principles and processes of Validation (Big V) have undergone some transformative alterations over the last few decades, and more recently as we entered the 21st Century. In fact, it was in the very name of the 21st Century that the US Food and Drug Administration provided the nudge (1). In this article, I review what...
A “signal-to-noise” (StN) approach is useful in addressing CAPA investigations of process excursions. This approach distinguishes between real process excursions and inherent process noise (variation). Process quality control points should reflect an understanding of the StN boundary and deal only with signals based on the process design. Key...
David LeBlond
Good decision-making is a key element in the assurance of pharmaceutical product safety and efficacy throughout the product life cycle. Good decisions require process knowledge. Process knowledge consists of a statement of a predictive model for the process plus estimates of the underlying model parameters. Three types of estimates are identified...
Pramote Cholayudth
The concept of using probability charts in the article entitled “Evaluation of Validation Content Uniformity Test Results Using Probability Distribution Charts,” published in the Journal of Validation Technology (JVT) (1), is applicable by its title to the content uniformity test—one of the critical quality attributes (CQAs) in process validation...
Fermentation may be simply defined as “a process for the manufacture of product by the mass culture of an organism” (1) The two basic components of fermentation are the organisms that biosynthesize the molecule of interest and the surrounding environment that supports organism growth and metabolism The most common organisms used in fermentation...
David E. Jones
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David W. Vincent
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Paul L. Pluta, Ph.D.
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Timothy J. Fields
This installment of the “Validation Learning Center” provides a summary of information on demonstration of process performance (i.e., the manufacturing of conformance lots). Recent documents and discussions have emphasized a comprehensive and integrated approach to the validation of manufacturing processes—the lifecycle approach to process...
Our sister journal, the Journal of GXP Compliance, features the ongoing column, “GXP Talk,” a column for discussion of issues identified by readers of the journal and the current good practice for resolution of those issues. Between 1993 and 2000, the US Food and Drug Administration prepared a series of communications from FDA headquarters to...
The first part of this series, “Don’t Bet on Quality by Chance, Part I: Taking the Guesswork Out of Validation,” (1) discussed the application of quality by design (QbD) to cleaning. 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...