GXP Journal Articles
Vol. 19, Issue 1, Mar 2015

William R. Porter, Ph.D.
An historical development of the concepts of measurement science leading to the issuance of the Guide to Expression of Uncertainty in Measurement (GUM) is presented. Early metrologists were aware that reported results of measurement processes were problematic and that some assessment of their uncertainty was required. This fell by the wayside...
Tim Sandle, Ph.D.
This article considerS pyrogens of microbial origin and the theoretical risks they pose to pharmaceutical products. The focus of the article IS with non-endotoxin pyrogens. The reasons for this are because of the voluminous content written about endotoxins and because non-endotoxin pyrogens often receive little discussion. Despite the low risk...
Paul L. Pluta, Ph.D.
Change control is a critical activity in regulated pharmaceutical manufacturing. Changes to manufacturing processes, formulations, equipment, cleaning procedures, analytical methods, and other systems are evaluated based on risk or impact. Appropriate validation / qualification work is then prescribed. “Like-for-like” changes are usually...
Jeanne Moldenhauer
When entering the pharmaceutical industry, one of the first training programs that must be attended includes the concept of “Good Documentation Practices. (GDPs)” The intent of this training is to ensure that the documents you generate, review, and / or sign are accurate and represent the work you conduct.. There are various sections of regulatory...
David Markovitz
Good Manufacturing Practice (GMP) is a quality system designed to help manufacturers produce quality products that are safe, pure, and effective. In theory, this is easy to do. In practice, however, there are several challenges. Manufacturing operations are comprised of multiple systems and processes. Effectively managing these systems and...
Jerry Lanese and Timothy J. Fields, editors
A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance and the Current Good Practice for Resolution of the Issues. This column is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to ask questions about, and express opinions on, current GXP issues....
Matthew F. Deraedt
Since the advent of penicillin, microbiologists and clinicians have noted the phenomenal ability of microbes to develop resistance to commonly used antimicrobials and antiseptics. Due to the imprudent use of antibiotics and the stagnation of the antibiotic development pipeline, antimicrobial susceptibility testing is becoming a vital utility to...
Tim Sandle, Ph.D.
Rouging can, arguably, never be avoided. Rouge formation is a steady chemical process that is underway in all metallic piping systems in contact with water and all stainless steels corrode over time as minor ingredients are lost and electrochemical potentials rise. What varies is the pace of the reaction. The process is exacerbated by high...
Paul L. Pluta, Ph.D.
In partnership with the Journal of Validation Technology, the Journal of GXP Compliance is pleased to present this "PQ Forum" review. “PQ Forum” is an ongoing feature in the Journal of Validation Technology (JVT) that provides a forum for validation practitioners to share information about Validation Stage 2 Process Qualification (PQ)...