GXP Journal Articles
Vol. 11, Issue 2, Jan 2007

Have you, the regulatory compliance auditor, ever been questioned regarding the basis for your findings? Have you ever wondered whether some of your findings were even worth mentioning in a report? Have you ever felt that you would not be doing your job if there were no findings to present at the end of the audit? Have you ever been questioned as...
Patient recruitment for clinical trials is now fully recognized as one of the most significant bottlenecks to successful study completion. Most sponsor companies have either assigned internal resources to assess and improve this function, developed sophisticated outsourcing structures to ensure appropriate external resources, or created a...
Steven S. Kuwahara
When dealing with the Good Manufacturing Practice (GMP) regulations as presented in 21 Code of Federal Regulations (CFR) 210 and 211, people may often forget that working with the GMP requires knowledge that goes beyond the material presented in the regulations. The regulations themselves often refer to other documents and regulations that should...
For the health sciences profession today, the benefits of assessing and managing risk have extended primarily from patient safety to the entire product lifecycle—from development through delivery.
The Pharmaceutical Industry is recognizing that it should strive for quality and achieve compliance as an outcome, rather than striving for compliance only. In the past, a sole focus on compliance has caused industry to not only do things for the wrong reasons, “because we have to,” but also in many cases, to do the wrong things. Precautions,...
David E. Jones
Training and the documentation of training are important tasks in Food and Drug Administration (FDA)-regulated firms. Firms with relatively few employees can and do function satisfactorily with paper-based training records. However, as the number of employees increase and the number of Standard Operating Proce- dures (SOPs) grows, many firms rely...
This article is one of a continuing series in which representatives of industry and the regulatory agency have an opportunity to express opinions on current GXP issues.