JVT Journal Articles
Vol. 13, Issue 2, Jun 2007

Pramote Cholayudth
This article is written as a complement to one recently published entitled – “Establishing Alert Limits for Microbial Counts in Purified Water,” which appeared in this Journal Volume 13, Number 1, November 2006. In the current paper, the scope will be expanded – i.e., establishing control limits for discrete quality data attributed to products,...
David E. Jones
‘Learning from mistakes’ is good advice and is often cited in business and operations management. The author agrees with the quotation, “The smart man learns from his mistakes. The wise man learns from the mistakes of others.” [Anonymous] Here are some opportunities to learn from the mistakes of others. Events, which are presented as...
The Food and Drug Administration (FDA) defines a network as: An arrangement of nodes and interconnecting branches A system that connects several remotely located computers via telecommunications Networks are a combination of hardware and software that together allow devices to communicate. Networks allow applications operating on various...
This article deals with developing a systematic CAPA program specifically addressing today's regulatory requirements. Not only does the U.S. Food and Drug Administra- tion (FDA) require programs for Corrective And Preventive Action (CAPA), but also many of us must comply with international requirements, and the analysis system in CAPA is one...
For small to mid-sized businesses, validation of information technology systems is a great challenge. Resources are limited and quality controls often fall victim to daily operational issues. And for start-ups and pre-clinical stage firms facing the Food and Drug Administration’s (FDA’s) push for “Quality by Design” into the development arena,...
Enhancing project performance during a “schedule crash” in a pharmaceutical environment is no straightforward task. Typically, it entails compressing the project's duration by adding more resources. This approach is high-risk as it usually leads to greater costs and diminished quality unless a solid infrastructure is put in place to mitigate...
Excellent responses to questions were received during the last months. Discussion of Questions 14, 15, and 16 are reported below. Responses demonstrated a variety of approaches to validation issues – the objective of “Benchmarking.” Thanks to our readers for sharing their approaches. Additional responses on questions from the last issues are...
Troy Fugate
With all of the work and focus on cleaning validation,1-7 one facet of the process often overlooked or not understood is the aspect of Hold Time Studies. So, what exactly are Hold Time Studies?