GXP Journal Articles
Vol. 14, Issue 4, Nov 2010

This article provides background on the importance of the records that support manufacturing of finished drug products. It focuses on the batch record review process and its importance as a vital step in the quest for quality in manufactured drug products. For those new to this industry, a bit of background may be useful to put the importance of the review of batch production records (BPRs) and other production and control...
The following key points are discussed: Cold chain can be defined as the supply and distribution chain for products that must be kept within a specific temperature range. Loss of control of required storage conditions may cause the product to lose integrity, stability, or potency rendering the product ineffective. All storage and handling...
In this issue of the column, the following key points are discussed: Change control as good business practice The importance of having a change control process in place Regulatory compliance drivers for change control Developing a change control procedure and process for computerized systems Determining the level of re-testing required...
The following key points are discussed: Functions of the Institutional Animal Care and Use Committee (IACUC) in a good laboratory practice (GLP) animal testing facility are discussed. GLP regulations and United States Department of Agriculture regulations govern the handling of animals in research and testing.
The following key points are discussed: Basic good laboratory practice (GLP) quality system requirements include the use of equipment that is properly designed and maintained. Each GLP laboratory should have a comprehensive, up-to-date list of all equipment used in the facility including active and inactive equipment. Each GLP laboratory...
“Have a safe flight.” This is what I hear from my wife whenever I leave on a trip that involves an airplane. These are the last words from her mouth when we part. I wish she wouldn’t say that, because I can’t think of a response that would leave her feeling comfortable.
The following key points are discussed: Cleaning validation acceptance limits are typically established based on a tiered approach. The first tier is the (patient) safety-based limit, and the second tier is the default limit (e.g., 10 ppm). Equipment is required to be visually clean after cleaning. After an adequate data set has been...
Kevin O’Donnell
Issues relating to subjectivity and uncertainty are known to arise during the execution of risk management and quality risk management exercises, and their existence is well documented in the scientific literature (1-8). There is widespread agreement that one of the core principles underpinning effective risk management is the principle that risk...
The following key points are discussed: The most probable number (MPN) method is familiar to quality control (QC) microbiologists as part of the microbial limits tests. Its usefulness goes far beyond this one test, however. The theory behind the MPN method is central to the commonly used D-value determination by fraction-negative method, and...
The following key points are discussed: A case study involving unexpected white spots on a previously problem-free blue tablet product is described. Initial speculation was that the white-spot problem was either grease spots or microbial growth. FD&C Blue #2 was the colorant in the tablet formulation. Chemical change (chemical reduction...
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 36 and 37 posed in the Summer 2010 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...