JVT Journal Articles
Vol. 18, Issue 1, Feb 2012

Manufacturing execution systems (MES) are increasingly commonplace in pharmaceutical manufacturing environments. MES are used for many purposes within manufacturing environments and can be interfaced with many different types of systems, equipment, and instruments. Control of the manufacture for pharmaceutical and medical device products is of critical importance to assure product quality and patient safety. Therefore, the...
In accordance with the 2011 FDA guidance for industry, Process Validation General Principles and Practices, there is a requirement to continue to verify equipment cleaning processes. This continued verification would reduce the risk of cross contamination, and consequently, the acceptable residue limits could be increased to reflect this reduced...
William V. Collentro
Current issues potentially affecting pharmaceutical water systems are discussed. These include chloramines, trihalomethane, and iron control in municipal water systems; regulatory requirements for methods of production, biofilms, rouging, and system documentation. Issues with potential for operational excursions are discussed.
Validation training must be compliant and effective. Effective and compliant training enables successful validation projects. This paper explores five critical elements that should not be overlooked when training personnel involved in a computer systems validation project.
Bernard McGarvey
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Brian K. Nunnally
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John McConnell
Before analytical error can be reduced, it must be understood. This means being able to separate assay and sampling error. A hierarchical study is an effective way to separate assay, sampling, and process errors. A hierarchical study retains the time order sequence of the data, making process investigation and improvement simpler. The best...
Michael H. Anisfeld
Worldwide, healthcare professionals and patients are experiencing shortages of oncogenic and other drugs. According to the United States Government Accountability Office, there were shortages of 220 finished drug products in 2011 (1). The US Food and Drug Administration’s coordinator of the Agency’s drug shortage program said that in 2010 54% of...
This article addresses the selection of the worst-case product grouping for cleaning vitamin and mineral oral dosage forms, and reviews data relating to solubility, toxicity and cleaning difficulty. The article also includes laboratory experiments on final formulations to assess cleanability of different vitamins and minerals.
Eugenie Webster (Khlebnikova)
This paper addresses the importance of professional development for validation professionals and the applications of topics from the American Society for Quality (ASQ) Body of Knowledge (BoK) for the Certified Quality Engineer (CQE) program. The ASQ CQE Body of Knowledge covers history and evolution of quality, quality management, statistics,...
Recovery factors (RF) are often used to interpret assay results for cleaning validation samples. Typically, the RFs are obtained by spotting coupons with the process soil that is to be cleaned and then subjecting them to simulated sampling conditions (e.g., manually swabbing or rinsing the coupons to estimate swab or rinse recovery factors,...
Alice Krumenaker
Laboratory systems represent a major section in the American Society for Quality’s (ASQ) Certified Pharmaceutical GMP Professional (CPGP) Body of Knowledge. The CPGP exam includes 20 questions from the “Laboratory Systems” section of the Body of Knowledge, which makes it the third largest portion of the exam. The “Laboratory Systems” chapter is...
David W. Vincent
The active pharmaceutical ingredients (API) and pharmaceutical product manufacturing industry is a complex global industry. While the United States and European pharmaceutical industries are experiencing little or no growth in this market segment, Asian producers are seeing high growth rates both from domestic demand and export sales. Countries in...
Paul L. Pluta, Ph.D.
Validation managers identified problems with validation sampling as one of their most troubling problems in process qualification (PQ) execution. Missing samples may have very significant consequences. When sampling requirements are complex and there is heightened potential for errors, designated sampling pages are recommended. These pages clearly...
John E. Lincoln
This discussion addresses methodology and documentation recommended by the US Food and Drug Administration to effectively address lifecycle considerations in software development. This includes steps to verify (or test) and validate software or firmware in a medical device to assist in performance, provide a display, accept input, or similar...