JVT Journal Articles
Vol. 20, Issue 2, Jun 2014

Biological products rely on a wide array of analytical methods for product characterization, lot release, and stability testing. As method improvement is a continued effort during the lifecycle of a biopharmaceutical product, bridging studies are often conducted to demonstrate comparability of the old and new methods. This paper discusses statistical considerations in the design and analysis of bridging studies for analytical...
Donald C. Singer
Good decisions are derived from accurate, timely information combined with adequate knowledge related to the problem being solved. Today’s pharmaceutical environment requires decisions about risk and contamination control. A mentality that incorporates a lifecycle or holistic approach to microbiological contamination control has been proven to be...
Ivan Soto
In recent years, several guidances and standards have been written and published on the topics of commissioning, qualification, and validation. Some of these guidance documents provide ideas for efficiency and cost saving. One of the key aspects of efficiency is the integration of commissioning and qualification activities. Additional concepts and...
William R. Porter, Ph.D.
The application of the Guide to the Expression of Uncertainty in Measurement (GUM) to pharmaceutical experiments in which the measured values are expected to increase from near-zero to larger values over time (kinetic studies) requires a reappraisal of how measurement results are reported and subsequently compared to specifications. Data...
Allan Marinelli
Due to the globalization effect, re-structuring of organizations, and emergence of fast-paced technologies, companies need to endorse efficient, effective methods when performing validation, especially at the performance qualification (PQ) phase, since there is a higher probability for US Food and Drug Administration scrutinization of the...
Jane Weitzel
“Any analytical procedure must be shown to be fit for its intended purpose before use.” The United States Pharmacopeia (USP) stimuli article (1) on the lifecycle management of an analytical procedure starts with this statement, emphasizing the importance of producing data that is fit for the decision being made using that data.
Tim Sandle
Rapid microbiological method technologies aim to provide more sensitive, accurate, precise, and reproducible test results when compared with conventional, growth-based methods. Rapid methods normally involve some form of automation, and the methods often capture data electronically.
Tim Sandle
Running an efficient laboratory requires the laboratory manager to balance the important aspects of compliance alongside the need to manage a budget and often scarce resources. Efficiencies can be generated by applying the philosophy of the “lean laboratory.” The “lean labs” approach focuses on cost control, improving sample throughput, and...
Robert Stianchi
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Diego Vargas
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Rizwan Sharnez, Ph.D.
The effectiveness of a pressure-driven leak of a gas in preventing microbial ingress was investigated experimentally (for an experimental investigation of pressure-driven leaks of liquids, refer to Sharnez et al 2007 [1]) (1). The leak was simulated by pumping sterile air through a 1 mm x 3 mm breach in a sterile container. The pressure drop...
John E. Lincoln
This Medical Device Column is on the subject of Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff,” issued June 28, 2013, by the US Food and Drug Administration (1). For those directly involved with such products, this is of major interest since it describes the proposed changes in...

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