GXP Journal Articles
Vol. 14, Issue 2, May 2010

The following key points are addressed in this article: Quality control microbiology test data are subject to significant variability, both avoidable and unavoidable Good microbiological procedures, backed by sound microbiological practices, can serve to do the following: Minimize avoidable variability Serve as a training structural framework Assist in investigations Provide assurance of good manufacturing practice...
The US pharmaceutical industry has experienced great advancements in development and control of manufacturing processes. The QbD effort (1) has transformed new product development in only a few years. The scientific community has responded through professional association collaborations and as individuals in publishing conceptual approaches,...
The following key points are discussed in this article: What are the principles of adult learning? Adults learn differently than children It is important to determine whether employees have really learned It is also important to determine whether employees remember the content of their training Do adults learn differently as they age? A...
The following key points are discussed in this article: A compliance case study involving defective packages is discussed A mutual trusting relationship with the vendor is key to problem resolution Emphasis is placed on the importance of understanding supplier and customer capabilities The effectiveness of quality controls is most often the...
The following key points are discussed in this article: Clean hold is the time between end of cleaning and the beginning of autoclave, sanitize-in-place (SIP), or production usage Global regulatory guidelines are consistent in the need for establishing clean hold Unless documented evidence can be provided as to why bioburden proliferation is...
The following key points are addressed in this paper: The recognition of sampling errors was originally reported by Gy. Pitard identified additional sampling errors. Data error is a newly identified error heretofore assumed in the errors of Gy and Pitard. Data errors are specific and unique and caused by different sources than the other...
The following key points are discussed in this article: The Environmental Protection Agency’s (EPA) good laboratory practices (GLPs) are based on the requirements of the Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act. The EPA GLPs contain provisions for conducting physicochemical testing.
The following key points are addressed in this article: On February 5, 2010, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) issued a final Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials The guidance furthers the US Food and Drug Administration’s...
Warning letters issued to a facility inspected by the US Food and Drug Administration for non-compliance issues are not uncommon. Many relate to violations by drug and device manufacturers or Internet sites violating FDA regulations. Some clearly fall into the category of objectionable practices related to 21 CFR 58, Good Laboratory Practice for...
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 32 and 33 posed in the Winter 2010 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...
Consider the following four words: Quality—distinguishing attributes of products and services that customers desire and for which they are willing to pay for Responsibility—moral and legal liability, reliability, trustworthiness Integrity—firm adherence to a code of moral and ethical values Accountability—to assume the sole and primary...