GXP Journal Articles
Vol. 13, Issue 4, Oct 2009

Louis Angelucci
The US Food and Drug Administration made effective 21 CFR Part 111, cGMPs for Dietary Supplements, on August 24, 2007 (1). This regulation has been anticipated in the dietary supplement industry for some time. It is a follow-up to the 1994 Dietary Supplement Health and Education Act (DSHEA) (2) ruling that established requirements for safety and...
Combination products are being developed in response to the increasing demands of patients requiring more advanced and more effective treatments There are less formal regulations governing combination products because the field is relatively new The US Food and Drug Administration’s Office of Combination Products was created in 2002 to oversee...
Gordon Welty, Ph.D.
Every organization in regulated industry must train its employees. This training is scheduled in several ways. There is a basic scheduling distinction between training that is delivered in response to a perceived deficiency in performance or qualification, and training delivered according to the calendar. Training according to deficiency in...
Paul L. Pluta, Ph.D.
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William Hall
This discussion of “Effective GMP” addresses key considerations in the development of manual cleaning procedures, documents reflecting these procedures, and their subsequent use in cleaning performance. Manual cleaning procedures may comprise the entire method of cleaning manufacturing equipment, or may be performed in conjunction with automated...
Michael H. Anisfeld
The year 2008 was a year of extreme contrasts for the US Food and Drug Administration. On the positive side, continuing advancements have been made in quality by design (QbD) and question-based review (QbR), as well as the evolving communication on the lifecycle approach to process validation. On the other hand, the nation experienced several...
Steven S. Kuwahara
This discussion compares US Food and Drug Administration Good Laboratory Practice (GLP) regulations with Environmental Protection Agency (EPA) GLP regulations Review of the EPA GLP regulations will show that a laboratory that is compliant with the EPA GLPs should have little trouble in claiming to be compliant with FDA GLPs EPA is charged with...
David Markovitz
Actions speak louder than words, and some of the best training occurs by example. Establishing a culture of quality within an organization, starting with upper most management, creates an environment that inspires employees to take pride in their work and, therefore, follow good practices. Companies that follow GXP regulations understand this...
Scott Sutton, Ph.D.
This article discusses the finalized harmonization of the Microbial Limits Tests. Changes to the respective tests and the ramifications of these changes are addressed.
Robert H. Smith
Businesses function in an electronic world where potentially sensitive information and data are stored on computers and networks. These same networks may be vulnerable to attacks that could result in corruption of data or loss of property. Information security should be an important part of any business practice. This article describes a...
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 28 and 29 posed in the Summer 2009 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...