GXP Journal Articles
Vol. 13, Issue 1, Jan 2009

A compliance case study involving equipment cleaning and inspection of cleaned equipment The event comprised cleaning of multiple equipment per procedure.
Running projects is common practice within many businesses and industries. Some companies have developed a formal project office that provides a final project model and project handbook, whereas other companies have a more informal structure for running projects. A generic and classic high-level model for project lifecycles contains phases...
Gordon Welty, Ph.D.
This article discusses the events and situations that, when observed and acted upon, initiate the revision of processes and procedures covered by good manufacturing practices (GMPs) in a regulatory industry such as that covered by the US Food and Drug Administration or other global regulatory agencies (1). Systematic pursuit of revision leads to...
The following key points are discussed: The purpose of quality control evaluation is to determine, with a high statistical confidence, whether or not the process mean or variability have changed All processes should be designed to produce a desired target value The choice of equipment, materials, methods, and training defines the predictable...
David Markovitz
Have you ever seen people drag themselves into the training room, groaning about having to sit through another boring hour of regulatory training? Sometimes they even bring other work with them. Have you wondered why people do this? Sure, the topic is usually pretty dry, but does training have to be this way? No. Regulatory training can be...
Patricia L. Smith
Sampling errors contribute to the overall variation in our results.
Many investigations end with the preventive action of corrective action and preventive action (CAPA) being retraining. If a sterile product repeatedly fails sterility testing we would quickly come to the conclusion that there is something wrong with the sterilization process.
Stainless steel meets regulatory expectations for process-contact materials but must be maintained properly Steel comes in many grades; different grades have different properties and the proper grade of steel should be selected for each application. 304L stainless steel is fairly standard for surfaces that do not contact the process, and 316L...
Optical microscopy provides insight to many compliance applications. Optical microscopes can provide characterization data for many pharmaceutical materials. With training and appropriate standards, the user of an optical microscope can provide valuable information and analysis in compliance activities, such as the identification of many...
Moisture may have a significant impact on a wide range of chemical, physical, and microbial properties of the finished pharmaceutical product Moisture in dosage forms comes from many sources including bulk drug, inactive excipients, manufacturing processes, and environmental conditions, and is a result of a variety of causes Water may interact...
The following are key points that should be considered in computer systems quality and compliance: An evolution has occurred regarding thinking and terminology from software validation to computer systems quality and compliance Computer systems include software, hardware, operating system, technical infrastructure, use and maintenance...
Cindy Green
Management of test facilities engaged in the conduct of studies regulated under good laboratory practice (GLP) (21 CFR 58) is required to clearly define the organizational structure and responsibilities of the assigned personnel (1, 2). This includes, but is not limited to, the requirement to designate a study director, establish a quality...
This article is one in 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 22 and 23 posed in the last issue of JGXP. The questions are repeated below and the responses follow.