GXP Journal Articles
Vol. 17, Issue 2, May 2013

The lifecycle approach to cleaning validation, according to Editor-in-Chief Paul Pluta, Ph.D, just makes sense. Cleaning is a process, and the validation lifecycle approach is consistent with QbD and International Conference for Harmonisation.
David E. Jones
It is difficult to imagine that one can say anything new about the need to prepare operating procedures, also known as standard operating procedures (SOPs), that are accurate, adequate and understandable by the user. The reader may apply other requirements, such as concise, clear, etc., in order for a procedure to be considered “good.” Numerous...
Lisa Howe, MsC
Elaine Harris
There are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’ The phenomenal growth and...
Gamal Amer, Ph.D.
Introduction This paper presents the case that good manufacturing practice (GMP) compliance is basically the continuous mitigation of risk to the consistent quality of the drug product throughout the manufacturing lifecycle. Risk, GMP, and GMP Compliance There is risk associated with every human activity and endeavor. What humans have...
Steven S. Kuwahara
In the previous series of papers, the Compliance Program Guidance Manual (CPGM) section that covers the inspection of GLP – regulated organizations and studies has 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 rules (5). Attention...
John E. Snyder
This paper explores the issues that can affect the ability of management to detect the warning signals of significant cGMP compliance problems and offers suggestions on how to gain control over this essential part of the business.
Alan Schwartz
Over the past year or so, you can see that US Food and Drug Administration has been taking a very “proactive” inspectional approach; the issuance of a very large number of warning letters. So, is FDA on a warpath judging by the ever-increasing number of facility inspections? Or, like any bureaucracy, have they have taken on too much work without...
James Kaar
Patrick Klemens
A quality audit is an important tool for any business to employ. When effectively used as an internal audit, the business will gain greater understanding of its compliance to applicable regulations and internal requirements. Further, the business can critically evaluate the suitability of its procedures and the health of the relationships within...