GXP Journal Articles
Vol. 12, Issue 5, Oct 2008

Timothy J. Fields
Conducting internal audits (self inspections) and external audits of suppliers and outsourcing operations are key elements of a good quality system. One aspect of a quality system that is identified in the recently released International Conference on Harmonisation (ICH) Q10, “Pharmaceutical Quality System” (1), and in other quality system...
Patricia L. Smith
The following key points are addressed in this article: Sampling variation, in addition to analytical variation, inflates the overall variation in our measurements, making it difficult to detect process variation of interest Sampling must be carefully performed to minimize its variation The four main sources of sampling variation are material...
Mid-infrared (MIR) spectroscopy has traditionally been used in good manufacturing practice (GMP) compliance as a tool to identify compendial chemical substances (1,2,3) and for chemical structure confirmation in investigational new drug (IND) submissions. MIR can also be used for a variety of other established GMP compliance activities.
In-line dilution is a process in which two liquid streams are brought together in a controlled fashion to meet an overall target concentration.
Process quality control points should reflect an understanding of the signal-to-noise (StN) boundary and deal only with real process signals based on the process design This approach is applicable for processes designed to meet their target attributes and processes that are statistically stable This approach distinguishes between real process...
Cindy Green
In the 1970s the US Food and Drug Administration uncovered a disturbing fact: Some of the laboratory studies supporting product registration were unreliable. To further assess their finding, FDA audited sponsor companies and contract laboratories to evaluate study integrity and data reliability. In 1975, FDA formed a task force to investigate...
Gordon Welty, Ph.D.
This paper considers the revision (the “versioning up”) of a standard operating procedure (SOP). Revisions that add value to a procedure can contribute to best practices. Revisions that do not add value are wasteful, and from a regulatory standpoint suggest that a process is not in control. Given the ubiquitous changes in technology, procedures...
“In the business world, the rearview mirror is always clearer than the windshield.” Although not speaking directly to the subject of investigations, Warren Buffet nonetheless provides the framework for how the industry chooses to address problematic issues. There is nothing surprising about seeing US Food and Drug Administration 483 and...
Jerry Lanese, Ph.D.
This article is one of a continuing series in which representatives of the industry and the regulatory agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to questions 20 and 21 posed in the last issue of JGXP. The questions are repeated below and the responses follow.