JVT Journal Articles
Vol. 19, Issue 1, Mar 2013

In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to...
Nancy Tours
Tim Sandle
The sterility test is an important end-product test for medicinal products that are required to be sterile (including those that are aseptically filled and many that are terminally sterilized, unless regulatory approval has been granted for parametric release) (1). The sterility test, as a culture based method, is described in the harmonized...
Bernard McGarvey
Brian K. Nunnally
John McConnell
The standard deviation calculated for any data set can be a meaningless statistic unless the data form a single population. Often, they do not. If the data are not stable, they do not belong to a single population. Either special causes or drifts in the mean will inflate the estimates for standard deviation. Too many scientists do not properly...
Pramote Cholayudth
Purified water (PW) is probably the only raw material essentially produced for internal use by pharmaceutical and other healthcare companies. The microbiological attribute in PW is hard to control when compared to control using an online conductivity meter and total organic carbon (TOC) analyzer. Although related guidelines, including World Health...
David LeBlond
Failure mode and effects analysis (FMEA) is a common and very useful approach to risk assessment; however, the ranking scales for occurrence (O), detection (D), and severity (S) ignore the importance of measurement scale choice. Risk priority number (RPN) = O×D×S is used to rank failure modes in FMEA. It is familiar, quick, and encoded in guidance...
Harry Yang, Ph.D.
Monte Carlo simulation, relying on computer-generated random numbers and statistical models to solve complex problems, has been widely used in engineering, science, and statistics. However, little known is its utility in resolving chemistry, manufacturing, and control (CMC) issues related to biopharmaceutical product manufacturing. This paper...
Jon Salomon
Ken Kopher
Vikram Patel
Yongqiang Zhang
Sterility is essential for the safety of a wide range of healthcare products such as injectable medicines, surgical devices, and implants. Among various sterilization processes, steam sterilization is perhaps the most widely used (1). To ensure the effectiveness of steam sterilization, regulatory agencies mandate the use of biological indicators (...
Luka Mladinov, PMP, CSM
Change is always around. This is especially true in the current globalized economic landscape wherein companies are facing changes on daily basis. Regardless of the nature, size, or impact of the change, it requires a degree of attention and management strategy. Some companies have elaborate and well-documented processes on how to manage changes;...
Biopharmaceutical cleaning and sterilization processes denature and degrade the active pharmaceutical ingredient (API)i into fragments that are pharmacologically inactive. A rational approach for setting safety-based acceptance limits for inactive fragments is described. The approach is based on the use of gelatin as a reference impurity. It is...
John E. Lincoln
The US Food and Drug Administration released its Code of Federal Regulations Title 21 Part 4, Current Good Manufacturing Practice Requirements for Combination Products, on January 22, 2013.

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