GXP Journal Articles
Vol. 12, Issue 2, Jan 2008

The simulation of an aseptic process with a culture medium does not automatically ensure that products routinely manufactured will have the same level of microbiological quality (Munson, 2004). Using media fill as a tool to gain knowledge about the process and not considering it an event of three satisfactory consecutive runs may improve the...
Although the letter of the law may not, strictly speaking, call for a CAPA process in the laboratory, the realistic laboratory professional working in today’s economy supplying domestic, European, and other international customers is accustomed to managing corrective and preventive action processes in the course of his or her work. This article...
Jerry Lanese, Ph.D.
Training and the Laboratories FDA investigators have found pharma and development laboratories ripe pickings for observations of noncompliance during audits. Guidances direct investigators to verify firms practice processes defined in their procedures. This article focuses on training designed for laboratory personnel applicable to both U.S. and...
Here, Good Clinical Practice(s) (GCPs) are viewed in both their current and potential state as central to the social enterprise called clinical research.
Jackelyn Rodriguez
Quality management methods, especially in high-tech industries, have undergone significant progress since 1978 when the current Good Manufacturing Practice (cGMP) regulations were last updated, and the Food and Drug Administration (FDA) wants to ensure that its regulatory practices encourage similar progress in the pharmaceutical industry.
Gordon Welty, Ph.D.
The ADDIE model is a generic design model. Our focus here will be the role of ADDIE for instructional design projects in Food and Drug Administration (FDA) regulated industry. The model provides guidance at a fairly high level for instructional designers, software engineers, and others as they author and revise training modules or courseware the...
Jerry Lanese, Ph.D.
The FDA regulation on Good Laboratory Practice deals with toxicology and preclinical studies. What most people want to know about good laboratory practice when they talk about GLP has nothing to do with the regulation 21 CFR 58, even if they don’t know that! The author clarifies the situation and proceeds to reasonable expectations for today’s...
Compliance costs your company at least $5,400 for each person who works with you1 - if you are doing everything right. Chances are, however, your company - like most of its peers - has redundant compliance and quality systems efforts that are costing you an additional 1.1% of your total revenue.2 To reduce costs, biopharmaceutical and medical...
This article is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to express opinions on current GXP issues Thank you for your responses to Questions 14 and 15 posed in the last issue of Journal of GXP Compliance. The questions are repeated below and the responses follow.
There is much to be desired regarding the general quality of the Quality Assurance groups that we have assessed or observed. In all too many instances, the companies' Quality Assurance groups (1) do not address a business or regulatory need, (2) focus on regulatory compliance issues of marginal importance while missing significant operational...