The Journal of GXP Compliance
Vol. 16, Issue 4, Oct 2012

In these discussions, the United States Food and Drug Administration Compliance Program Guidance Manual (CPGM) for good laboratory practices (GLPs) is being reviewed to provide the reader with information on the topics that may be addressed during a GLP inspection. In addition, the Guidance Manual; available online (1) at the FDA website, is a useful guidance document for workers who are new to audits of contract laboratories...
David E. Jones
David Markovitz
Many companies struggle with developing and implementing an effective good manufacturing practice (GMP) training process. There are several real and perceived obstacles that often get in the way of making a solid commitment to provide the training required by the GXP regulations. The cost of poor or inadequate training can be staggering. Rework,...
Cliff Campbell
Paula Katz
This article is based on a technical training seminar presented to United States Food and Drug Administration policy advisors, management, and field staff in Silver Spring, Maryland, in May 2012. It summarizes the regulatory drivers that led to the publication of FDA’s 2011 Process Validation Guidance for industry. In particular, the article...
A. Mark Trotter
Alice Krumenaker
Rick Calabrese
Ulo Palm, Ph.D.
GXP regulations are in place to ensure the purity, quality, and safety of pharmaceuticals. Manufacturing and quality control testing of approved drugs falls under good manufacturing practice (GMP) regulations. Safety studies for drugs are regulated by good laboratory practice (GLP) regulations. There currently are no guidelines for drug discovery...
Lynn Torbeck
United States Pharmacopeia (USP) <1010> Appendix E describes the use of statistical tolerance intervals when comparing data sets between analytical methods. This technique overcomes problems often observed when using the t-test for such comparisons, (i.e., differences between data sets are statistically significant but are not of practical...
Kristin Jarrell
A tragic incident involving the poisonings of multiple Chicago-area residents due to adulterated Tylenol capsules occurred 30 years ago. This tragedy led to new tamper-resistant packaging regulations, many of which are still in place today (1-4). These current practices, adopted for drug and food packaging, are crucial to production safety...
Jerry Lanese
Timothy J. Fields
“GXP Talk” discusses issues identified by readers of the journal and provides current good practice to resolve those issues. We encourage readers to ask questions about compliance issues that are challenging to their firms or to industry. We also encourage readers to respond with opinions as to how to resolve the question or issues presented,...
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