GXP Journal Articles
Vol. 12, Issue 3, Apr 2008

Michael H. Anisfeld
China is a land of superlatives and contradictions. The world’s largest country by population, China has the world’s longest wall—visible from outer space. It has a magnetic levitation train that runs at over 400km/hour. China has several mega-cities, the largest having a popula- tion of over 30 million, and is the world’s largest consumer of coal...
Karen Ginsbury
The ICH Q10 draft document on “Pharmaceutical Quality System,” states that: “The change management system ensures continual improvement is undertaken in a timely and effective manner while providing a high degree of assurance there are no unintended consequences of the change (1).” It is clear that the purpose of change management is to prevent...
Using Six Sigma tools in change management requires some fundamental understanding of Six Sigma and change management. This article describes some of the basic principles of change management and discuss how to work with Six Sigma and an existing change control process to make use of both aspects while enabling the two to co-exist symbiotically....
Timothy J. Fields
Many aspects of pharmaceutical manufacturing rely on stability, consistency, and maintaining a state of control to ensure that a safe, efficacious, and quality product is produced for the patient. Procedures are written and personnel trained to ensure that tasks are performed in a controlled manner. Processes are validated to demonstrate that the...
Gordon Welty, Ph.D.
This article is the fifth in a series on training and the ADDIE Model. The first article, “Strategy and Tactics of Task Analysis,” appeared in the Journal of GXP Compliance, Volume 11, Number 3, April 2007; the second appeared as “The ‘Design’ Phase of the ADDIE Model,” Volume 11, Number 4, July 2007; the third, “Developing Assessments of Trainee...
David LeBlond
In this first installment of “Statistical Viewpoint” the author discusses the following points: Data should not be considered exact values, but thought of as estimates randomly drawn from a population because on repeated measurement, they exhibit different values Underlying parameters are known only with uncertainty and should be considered...
It is an oft-quoted mantra of the GMP-training industry that when the company as policy, or the individual staff member, does not follow GMP principles, people die. But, is this true? Does the failure to follow GMPs actually lead to patient injury or even death?
Recent developments in the ongoing concern over the safety of products imported from China have created pressure on the US Food and Drug Administration (FDA) to improve its inspection of foreign plants and imported products. There has been significant media coverage and exposure concerning the recall of drug products, lead-based paint on toys, pet...
This article is one of a continuing series in which rep- resentatives of the industry and the regulatory agency have an opportunity to express opinions on current GXP issues. Thank you for your responses to Questions 16 and 17 posed in the last issue of JGXP. The questions are re- peated below and the responses follow.