GXP Journal Articles
Vol. 14, Issue 3, Jul 2010

Self-inspection is a well-established part of the pharmaceutical quality system. Companies have traditionally been using it as a method for monitoring the implementation and compliance with good manufacturing practice (GMP) principles, as well as for introducing appropriate corrective measures. This role of self-inspection is promoted by the current GMP legislation and guidance (1).
The following key points are discussed: A case study involving a batch size increase for a liquid solution product is described The batch size increase was considered to be a relatively simple change because other similar products at the site were already manufactured at the same increased batch size and the equipment to be used was “identical...
The following key points are discussed: This case study describes manufacturing of a tablet product in which an abrupt and unexpected change in the manufacturing process occurred. Tablet compressing became extremely difficult including breakage of tablet compressing punches Potential causes for the problem to be investigated were identified...
The following key points are discussed: US Food and Drug Administration good manufacturing practice (GMP) requirements regarding yield require that product be formulated to provide 100% of the labeled amount and that actual yields and percentages of theoretical yield be determined at the conclusion of each appropriate phase of manufacturing.
The following key points are discussed in this article: Good laboratory practice (GLP) animal studies are regulated by GLP regulations (1) and US Department of Agriculture (USDA) regulations (2). USDA regulations are national regulations just like the US Food and Drug Administration regulations An institutional animal care and use committee (...
Lynn D. Torbeck
A previous issue of “Effective GMP” discusses “Effective Training” (Journal of GXP Compliance, Summer 2009, Volume 13, Number 3) and the following key points that should be considered in management of a GXP training program: Training policy, standards, and procedures documented Training process strategy and approach defined Principles of...
An illustrative incident at a pharmaceutical company that is representative of actual events is discussed. This incident involves software control of a drug dispensing system in pharmaceutical manufacturing. An error in amount of drug weighed occurred. The investigation identified several problem areas. Lessons learned, areas of concern,...
The following key points are discussed in this article: The routine environmental monitoring program is a critical aspect of documenting the state of control of the facility Recommendations for the selection of sample sites to be used in the qualification program are provided. These recommendations are directed at providing data to allow...
I had just arrived at the airport in Memphis, Tennessee for an early morning flight. As I approached the security area, there was only one person in front of me in line—a man in his early 20s. As this man was preparing to load his belongings into the bins to go through the x-ray machine, he started patting his pockets and said aloud, “Oh no! I...
The following key points are discussed: Two-piece hard capsules are a well-established, widely used dosage form with a long history in the pharmaceutical industry Two-piece capsules offer speed of development versus tablets as well as flexibility of fill materials The filling process for two-piece capsules is a robust process and can be well...
The following key points are discussed in this article: Cleaning methodologies have evolved significantly over the past 20 years; nonetheless, some practices are not adequately defensible, and many of the approaches are not truly science-based.
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 34 and 35 posed in the Spring 2010 issue of the Journal of GXP Compliance. The questions are repeated below and the responses...