GXP Journal Articles
Vol. 18, Issue 1, Feb 2014

To a large extent, our ability to properly select and monitor suppliers for our key pharmaceutical manufacturing materials and services is a primary factor in our success. Despite strict controls, inspection, and testing for incoming materials, the activities we undertake even prior to that first shipment will predict overall success in four key areas.
Joan E. Adamo
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Sandra K. Hancock
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Catherine M. Bens
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Marilyn Marshall
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Leigh B. Kleinert
,
Marcella Sarzotti-Kelsoe
Translational research involves bringing promising candidate drugs, biologics, and medical devices from the research bench into use at the patient’s bedside. Many of the pathways taken during this process are governed by federal guidelines and regulations. Academic institutions often are at the forefront of innovative and translational research...
Sheri Hampson
Most information technology (IT) organizations understand the importance of a robust change control process. Most life science organizations understand the importance of maintaining the validated state of their computer systems. A dilemma occurs when the change control process and the computer system validation process have to meet. The...
Mark Ciceran
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Troy Fugate
This paper discusses the critical approach necessary to develop a quality remediation plan for inspectional observations (i.e., FDA Form 483) submitted by US Food and Drug Administration. We will examine the importance of having a detailed understanding of the observations and their impact on all quality sub-systems. Management will need to ensure...
Steven S. Kuwahara, Ph.D.
In the previous series of papers, the Compliance Program Guidance Manual section that covers the inspection of good laboratory practice (GLP)-regulated organizations and studies has been discussed (1–5). This document, referred to as CPGM 7348.808, covers the US Food and Drug Administration’s inspection of studies that are conducted under GLP...
Joe Zec
In today’s life sciences industry, software is playing an increasingly critical role in business operations. From clinical trial data collection to complaint handling systems, from laboratory information systems to manufacturing execution systems, software is growing in size and complexity, presenting a validation challenge. Validation frameworks...
Noreen Muscat
,
Robert Sims
In the past five years, cloud computing adoption has grown steadily. According to a July 2012 CompTIA report, 93% of companies are using some form of cloud solution. Gartner predicts cloud computing will grow by over 100% to become a $207 billion industry by 2016; meanwhile, the overall global information technology (IT) market is forecast to grow...
Siegfried Schmitt
Pharmaceutical companies have outsourced large portions of their activities, such as drug development, active pharmaceutical ingredient (API) manufacture, drug product manufacture, packaging, drug product release by a qualified person, or quality control (QC) testing. These outsourcing activities are often of a complex nature and carry significant...
Ivan Soto
,
Robert Reddick
Historically, the relationship between Quality and Validation has been dysfunctional, unproductive, and inefficient. These issues have had a negative impact in the operation of each organization. The negative impact translates to unnecessary delays in projects, increased cost, low morale, and conflict between the two organizations. This article...
Jerry Lanese, Ph.D.
,
Timothy J. Fields
This column is one of a continuing series in which representatives of the industry and regulatory agencies have an opportunity to express their opinions on current GXP issues. Thank you for your responses to the questions posed in the last issue of the Journal of GXP Compliance. They follow.