GXP Journal Articles
Vol. 15, Issue 3, Jul 2011

The following key points are discussed: Dissolution testing is important because it is the only test that addresses product performance Dissolution methods may be developed for different purposes and must be appropriately validated As with other methods, it is important to consider the entire method lifecycle When developing, validating, or...
The following key points are discussed: Quality control microbiology tests require controlled levels of inocula and require fresh preparations of cells for those inocula The concentration of cells in a suspension can be estimated by optical density, but this must be confirmed by plate count The optical density readings against cell mass are...
Good laboratory practices (GLPs) have been universally recognized as rules that govern the conduct of non-clinical safety studies. The GLP goal is to ensure the quality, integrity, and reliability of the data developed from such studies, which in turn allows the appropriate assessment of the safety and effectiveness of the drug or device that is...
Everyone has an idea of what constitutes excellence, yet few can define it well. Some would say that excellence is the performance of activities at a high level of competence. Others define excellence in terms of sports teams, individual leaders, automobiles, or abilities. Many would say that excellence, though hard to define, is easy to spot....
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 42 and 43 posed in the Spring 2011 issue of the Journal of GXP Compliance. The questions are repeated below together with...
The following key points are discussed: Principles and considerations addressed in the “Laboratory Systems” section of the ASQ Body of Knowledge are necessary before any good manufacturing practice (GMP) samples can be tested in the lab. Instrument control and recordkeeping including calibration are key areas of laboratory operations....
The following key points are discussed: While particle size analysis can provide great insight in the pharmaceutical industry, it can be nearly meaningless if obtained improperly. A particle size distribution can be found for both colloidal dispersions (containing particles <1 μm) and suspensions (containing particles >1 μm).
Processing biotech active pharmaceutical ingredients (APIs) under aseptic conditions is not required by regulations. However, good manufacturing practice (GMP) regulations state that the control of microbiological contamination should be appropriate in relation to risk to the patient (1 [§113], 2 [§6], 3, and 4).