JVT Journal Articles
Vol. 18, Issue 4, Nov 2012

This article is based on a technical training seminar presented to United States Food and Drug Administration policy advisors, management, and field staff in Silver Spring, Maryland, in May 2012. It summarizes the regulatory drivers that led to the publication of FDA’s 2011 Process Validation Guidance for industry. In particular, the article emphasizes that process validation is a meaningful scientific endeavor that strives...
Bernard McGarvey
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Brian K. Nunnally
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John McConnell
Shewhart’s original ideas on the control of quality were applied to an individual manufacturing process. After Shewhart, his ideas have been applied to a much wider arena than individual manufacturing processes. This expansion in the application of Shewhart’s ideas is important to realize the full benefits of statistical thinking. This must be...
Jeanne Moldenhauer
Since the advent of the US Food and Drug Administration’s Systems-based Inspections Pilot Program in 2000, and its subsequent issuance (1), as well as the FDA’s Current Good Manufacturing Practices (GMPs) for the 21st Century (2), industry has been advised that there would be a change in how FDA inspections of pharmaceutical manufacturers would be...
Scott Sutton, Ph.D.
United States Pharmacopeia (USP) <1116> “Microbiological Control and Monitoring of Aseptic Processing Environments” approaches analysis of environmental monitoring (EM) data in the aseptic core from a perspective of “contamination recovery rates” while noting a need to improve EM data analysis.
For multiproduct cleaning validation, the conventional approach for setting an acceptance limit for the process residue is based on the maximum allowable carryover (MAC) of the active pharmaceutical ingredient (API) (depending on the process soil, API refers to the active pharmaceutical ingredient in the drug product, drug substance, or drug...
Harry Yang

The US Food and Drug Administration 2004 Guidance and the Code of Federal Regulations (CFR) governing the manufacture of pharmaceutical products (21 CFR 211) clearly state the need to establish and follow procedures to prevent microbiological contamination of sterile drug products (1). Univariate statistical control charts are often used to...
Carol Bartnett
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Dan Klein
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Jim Polarine
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Peter Karanja
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Tom Smith
Quaternary ammonium compounds (QACs) are excellent active ingredients in disinfectant products; they have low toxicity, good detergency, and bactericidal efficacy. Unfortunately, many currently marketed QAC products are incompatible with some forms of sterilization and provide insufficient fungicidal activity. These drawbacks can prevent the use...
Michelle C. Killilea
In 2007, Viracept tablets were recalled from the European Union (EU) market when it was found that Viracept (nelfinavir mesylate) manufactured in Roche’s Switzerland plant was contaminated with highly toxic ethyl mesylate. The Viracept marketing authorization was subsequently suspended. Investigation indicated substandard cleaning validation...
Paul L. Pluta, Ph.D.
KEY POINTS -Validation results pages are formatted pages containing test results from a validation testing scheme. -Validation results pages minimize various problems with validation results, including missing results and disorganized results. -Results pages facilitate results review in the test area, technical review of results, and validation...
John E. Lincoln
As the medical device industry moves toward electronic records (ER) and signatures by in-house systems and/or cloud/web-based systems, and away from paper documentation, 21 Code of Federal Regulations (CFR) Part 11, Electronic Records; Electronic Signatures (ES) verification and validation (V&V) activities and documentation become mandatory....