GXP Journal Articles
Vol. 13, Issue 3, Jul 2009

This discussion addresses the need for analytical method validation in good laboratory practice (GLP) studies including stability studies Regulations clearly state that stability studies must be done and completed no later than the end of the GLP study. Responsibility for appropriateness of testing and completion of stability studies rests with test facility management. Stability of test mixtures containing active drugs...
Patricia L. Smith
The evaluation of suspect data may be enhanced by careful and thorough evaluation and analysis of potential sampling errors Conclusions and decisions are based on data, and data may be greatly affected by sampling Each of the following contributes to variation in final data results: Material, process, sampling, and lab Ten errors and sources...
Selection and maintenance of appropriate compression tooling is an important consideration in tablet manufacturing Tooling problems during commercial manufacturing are difficult to predict Tooling problems may be caused by moisture content, granulation particle size, abrasiveness of formulation, and other factors Careful evaluation of punch...
Gordon Welty, Ph.D.
A new employee orientation (NEO) program can contribute to both GXP compliance and organizational productivity. New employee orientation can contribute to GXP compliance by indicating to the new hire or transferring person that the organization (and the regulatory agency) has a series of expectations for employee performance in the workplace....
In today’s environment of technology and automation, it is important to understand disaster recovery (DR), business continuity (BC), and contingency plans (CP) and how they all work together to ensure continuity and integrity of systems and availability of data and records System owners and technology professionals should understand how these...
The cornerstone of compliant operations in a US Food and Drug Administration-regulated industry is properly trained personnel who successfully perform their day-to-day functions according to approved procedures. Training of personnel is a key element supporting successful performance. Training that is well designed, conducted efficiently, and...
David LeBlond
Tukey’s test can be used to compare the means of multiple groups when the within-group variation is normal and all groups have the same true variance. This test is a Neyman-Pearson type test that maintains a desired family-wise Type I error rate. It is based on the Studentized range distribution. Bartlett’s test can be used to compare the...
David Markovitz
GXP regulations require that GXP training be conducted on an ongoing basis. One of the biggest challenges in GXP training is keeping the training fresh. It’s a topic that tends to change with glacial slowness. Keeping the trainees interested can be difficult if you are teaching the same things over and over. Here’s a tip on keeping your GXP...
Scanning electron microscopy (SEMs) and energy dispersive x-ray spectroscopy (EDS) provide useful information about the microstructure of pharmaceutical powders and oral dosage formulations, including particle sizing, active pharmaceutical ingredients (API) characterization, and identification of extraneous matter from production, development, or...
Process water coolers are used for manufacturing processes that utilize hot water-for-injection (WFI) as the water source, but require the water to enter the process at a temperature less than 80°C A PID controller is a device that uses feedback control, a mathematical algorithm with proportional, integral, and derivative equations, and...
This article is one of a continuing series in which representatives of the industry and the regulatory agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to questions 26 and 27 posed in the Spring 2009 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...