GXP Journal Articles
Vol. 17, Issue 3, Aug 2013

At IVT's 2nd Annual Validation Week Canada, Eugenie Webster (Khblenikova) presented on the new regulatory focus on statistical process control (SPC). The regulatory expectations were discussed, including the purpose of the regulatory requirements, determining which processes need monitoring and control, and understanding manufacturing process variations.
Sofia Cerioni, Ph.D.
Companies regulated under good manufacturing practices (GMPs) are routinely inspected by health authorities in order to ensure the quality, safety, and efficacy of their products. Accordingly, the study has two objectives: firstly, to point out where the inspectors’ attentions are focused and to highlight the main deficiencies of the company and,...
Richard C. Wedlich
This paper is intended to provide useful hands-on guidance regarding the process of provider qualification. What we have learned of this comes mostly from being employed in smaller contract research organizations (CROs) that have been focused on providing good manufacturing practices (GMP) and good laboratory practices (GLP) support to major...
John E. Snyder
The focus here is on the crucial responsibilities of quality system owners and the need for senior management to set performance expectations of quality system owners and provide support to succeed in a dynamic business environment.
Orlando Lopez
In the life science industries, plenty of attention is placed in the validation of computer systems during the development of new systems and associated infrastructure. After deploying the computer systems to support operations, the operational life of these systems initiates.
Steven S. Kuwahara
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 have been discussed (1 – 4). This document, referred to as CPGM 7348.808, covers the US Food and Drug Administration inspection of studies that are conducted under GLP...
David Markovitz
Multitasking is a word that has crept into our vocabulary in the past decade or so. Multitasking has taken on broad definitions, including doing more than one task at the same time, dealing with shifting priorities, managing multiple projects, doing more work than time permits, and many other situations. Many people take pride in their ability to...
Scott Sutton, Ph.D.
The use of social media has exploded in recent years. This has been a disruptive change, affecting the recording, broadcast, and print industries, among others. However, the individual social media technologies as a means of communication and training have generally been derided in the media due, in part, to the generally youthful nature of the...
James Kaar
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Patrick Klemens
The last of our story in the series The Business of Auditing and Auditing the Business. Welcome to the last chapter in the “Audit Forum” story. This series has endeavored to provide an overview of a critical activity in compliance—auditing and being audited. This series explored many dimensions of the audit process beyond the audit event to...