JVT Journal Articles
Vol. 19, Issue 4, Dec 2013

The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Institute of Technology (DIT) in Ireland, conducted a recent industry survey to assess: The current range of process monitoring activities typically performed during commercial manufacture of a product The level of implementation of continued process verification programs in industry today. The research hypothesis acknowledges the need...
Adam Mott
Bill Henry
Edward Wyman
Greg Randall
Kathleen Bellorado
Markus Blümel
Mary Ellen Clark
Michael Parks
Ronan Hayes
Scott Runkle
Wendy Luo
For multi-product biopharmaceutical facilities, setting the acceptable level of process residues following equipment cleaning is an important regulatory, business, product quality, and patient safety consideration. Conventional approaches for setting an acceptance limit for process residues have been based on the assumption that the active...
Eugenie Webster (Khlebnikova)
This paper discusses an application of statistics in analytical method validation. The objective of this paper is to provide an overview of regulatory expectations related to statistical analysis and the review of common statistical techniques used to analyze analytical method validation data with specific examples. The examples provided cover the...
William V. Collentro
Over the past several years, harmonization of compendial water specifications has generated a debate regarding the method of producing Water for Injection (WFI) in bulk. While United States Pharmacopeia (USP) states that, “Water for Injection is water purified by distillation or a purification process that is equivalent or superior to distillation...
Jane Weitzel
Quality-by-design (QbD) is being used successfully for production processes; the same QbD approach can be applied to analytical procedures. QbD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” (1...
Sebastian Clerkin, Ph.D.
Many medical device manufacturers find it a considerable challenge to plan and conduct a cleaning validation. The main challenges are an establishment of the cleanliness limits and an identification of the challenge conditions to be assessed during the process validation. This paper describes a logical risk-based approach to overcome these...
Ziva Abraham
Mold contamination has been considered a hazard in residential and commercial buildings for many years. In the past few years, however, mold contamination issues in pharmaceutical products have caught the attention of regulators.
Pramote Cholayudth
Introduction Process capability index (CpK) is one of the most commonly used statistical parameters for measuring and improving the processes as far as statistical process control (SPC) is involved. It is the process performance metric often used in all of the three stages of process validation (i.e., process design, process performance...
Bernard McGarvey
Brian K. Nunnally
John McConnell
Before we can reduce analytical error, first we must understand it. All laboratories have an obligation to provide their customers with test results with minimum analytical error. Analytical error includes sampling error. Sampling error and between analyst variation are the most commonly found sources of variation in pharmaceuticals...
Crystal Booth
Obtaining successful validations of certain raw materials and finished products can be tricky. Researching the materials beforehand is important. By working closely with development scientists and chemists, setting appropriate specifications, and performing research, method development trials can be streamlined to produce an adequate method.
John E. Lincoln
he US Food and Drug Administration, Center for Devices and Radiological Health (CDRH), announced their long-anticipated Unique Device Identification System Final Rule on September 23, 2013. FDA’s stated purpose for this final rule is “to establish a system to adequately identify devices through distribution and use. This rule requires the label...

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