GXP Journal Articles
Vol. 15, Issue 1, Feb 2011

This paper is the second of two papers that further develops some of the key points made in an article published in the Journal of Validation Technology in February 2007 (1). That 2007 paper, titled “Simple Strategies for Improving Qualitative Quality Risk Management Exercises during Qualification, Validation, and Change Control Activities,” addresses how problems of subjectivity and uncertainty associated with the outputs...
Many companies conduct GXP training on a schedule based on the calendar, usually on an annual basis. This approach to training is good, but it is not good enough. Annual training may not take advantage of events or episodes where GXP training can be made more relevant and more meaningful. Training sessions should also be conducted when the...
The following key points are discussed in this article: The information contained in a quality plan (QP) is critical to the success of a project in meeting its quality goals The extensive use of software in computer systems requires that the QP address software compliance in its many facets, sometimes with a separate software quality assurance...
The following key points are discussed: Environmental monitoring is a proceduralized recurring set of activities for evaluating air and surfaces for viable or non-viable particles as well as other environmental variables. The chief function of environmental monitoring is informational feedback on environmental control, disinfection and...
The following key points are discussed: There are well-known fundamental ideas and tools associated with monitoring process quality and with process improvements. These ideas have been packaged and repackaged under different names and have taken on fad status.
The following key points are discussed: Cold chain is the supply and distribution chain for products that must be kept within a specific temperature range. Compliance practitioners must be aware of the regulatory requirements and appropriate practices to ensure that the handling and distribution of drug products and their components are under...
The following key points are addressed in this article: Rats and mice, along with birds bred for experimental purposes, are exempt from the requirements of the Animal Welfare Act. The exclusion applies strictly to rats of the genus Rattus and mice of the genus Mus that are bred for research purposes.
The following key points are discussed: Testing facility management is the person(s) who has the authority and formal responsibility for the organization and functioning of the testing facility according to the principles of good laboratory practice A testing facility will have three levels of management: facility management, study personnel...
The following key points are discussed: The healthcare industry is currently in a period of seemingly opposing objectives—cost cutting during a period of increasing US Food and Drug Administration enforcement of compliance deficiencies. This discussion addresses the identification of areas in which we cannot minimize compliance focus while...
Michael H. Anisfeld
Current good manufacturing practices (GMPs) have been around for a long time. Their origins can be traced to the Canadian QUAD requirements of 1959, the US GMPs of 1963 (updated to their current form in 1976), the British Orange Guide of 1971, and the Pharmaceutical Inspection Convention GMPs of 1972, which morphed into the European Union GMPs in...
This article is one of a continuing series in which representatives of the industry and the regulating agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to questions 38 and 39 posed in the Autumn 2010 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...