GXP Journal Articles
Vol. 14, Issue 1, Feb 2010

The US Food and Drug Administration is coming to a tobacco manufacturing plant near you. You may not be near one of the large cigarette factories that once dotted the southeastern states, but you may be near one of the many smaller tobacco product-manufacturing plants or one of the manufacturers of components of tobacco products that FDA wants to regulate. FDA has concluded that all such operations are in its purview,...
Michael H. Anisfeld
During the many years I have performed inspections for clients, I have seen many instances of animals being where they don’t belong—on the manufacturing floor. Reflecting over my years of performing good manufacturing practice (GMP) audits worldwide, there have been many occasions that animal issues in pharmaceutical or in active pharmaceutical...
The following key points are discussed in this case study: A compliance case study involving manual cleaning, performance and responsibilities of manufacturing personnel, supervisors and quality control (QC) personnel, and training supporting all involved is discussed. The event comprised cleaning of manufacturing equipment per procedure.
The following key points are discussed in this case study: A compliance case study involving cleaning validation and the observation of unknown peaks in high performance liquid chromatography (HPLC) chromatograms is discussed Unknown peaks were observed from testing of swab samples following cleaning of suspension products containing insoluble...
The following key points are discussed in this article: US Food and Drug Administration current good manufacturing practices (CGMPs) provide fundamental requirements for pharmaceutical manufacturing The FDA 483 is the official recording of FDA investigator observations from an FDA inspection An inadequate inspection response is the primary...
The following key points are discussed in this article: Tablet compressing is an established manufacturing process with multiple applications in pharmaceutical, dietary supplement, food, cosmetic, diagnostic, and other industries The most important performance characteristics of tablet dosage forms are identified Actual tablet compressing may...
The following key points are discussed in this article: Good personal hygiene is a requirement of all pharmaceutical activities, from operating on the line through laboratory good manufacturing practice (GMP) studies. However, studies show poor hand washing compliance is the rule in a variety of occupations. Poor hand washing technique may...
The following key points are addressed in this article: Swab sampling is a direct surface sampling technique for sampling surfaces Personnel who perform swab sampling should be qualified for performance Swab efficiency (i.e., % recovery) for the method and product contact material should be determined Extractables from the swab or protein...
The following key points are addressed in this article: This discussion addresses physicochemical (non-animal) testing in good laboratory (GLP) facilities US Food and Drug Administration GLP regulations do not address physicochemical testing Environmental Protection Agency GLP regulations do address physicochemical testing EPA GLP...
This paper discusses qualification of specific categories of employees in a GXP environment. Employee categories addressed include production operators and technical subject matter experts (SMEs). These personnel are designated for specific critical tasks in an organization. Concepts discussed herein are also applicable to laboratory analysts...
The following key points are discussed in this case study: A compliance case study involving fundamental problems in equipment qualification at a drug product packaging facility is discussed.
Designing, upgrading, and continually maintaining good laboratory practice (GLP) facilities are critical factors in compliance with regulatory requirements and in producing top-notch study results, regardless of the setting. By having a working knowledge of the regulations, using preparation tools for working with architects, and maintaining...
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 30 and 31 posed in the Autumn 2009 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...