The Journal of GXP Compliance
Vol. 20, Issue 5, Sep 2016

Lynn D. Torbeck
The following key points are discussed: This discussion describes an actual event involving rejects in a tablet compressing process. Statistical evaluation of all data (passing and failing) provided a much different conclusion compared to the original evaluation. Data collection without understanding and integration of all available data...
Paul L. Pluta
The following key points are discussed: One of the first significant and critical activities conducted in an audit is the plant tour. The plant tour is a critical activity that must be considered to be of utmost importance. There are many overlooked items on the plant tour that can negatively affect the entire audit. Experience has shown that...
Scott Sutton
The following key points are discussed: The client organization is responsible for their product and by good manufacturing practice (GMP) responsible for all data and analysis that contribute to the decision to release a batch of product to the marketplace. Contract lab reports must provide sufficient information to meet regulatory expectations...
Steven S. Kuwahara
ABSTRACT This article provides an overview of the US Food and Drug Administration’s good laboratory practice guidelines found in the compliance program guidance manuals. INTRODUCTION
Tim Sandle
This paper considers some of the potential causes for wet loads and addresses some of the measures that can be taken to address occurrences.
Michael H. Anisfeld
The litany of major multi-national pharmaceutical companies failing to follow US Food and Drug Administration regulations for good manufacturing practice (GMP) keeps going on and on. In 1999, Abbott Laboratories was fined US$100 million. In 2002, Wyeth-Ayerst was fined US$30 million, and Schering-Plough was fined US$ 500 million. And in October of...
Eric Olson
Fine particle characterization is most effective when accomplished through a methodical process. The first step of this process often involves determining what material needs characterization.
Paul L. Pluta
Change control is a critical component in regulated pharmaceutical manufacturing and quality systems. Changes to manufacturing processes, formulations, equipment, cleaning procedures, analytical methods, and other systems are evaluated on risk or impact. Complicating these judgments are emergency situations when changes must be made to maintain...
Cindy Green
The following key points are discussed: An essential part of a study performed under good laboratory practice is the study record The study record contains what was done, how it was done, when the work was performed, and who performed the work Good documentation and recordkeeping practices that are applied to all site records are vital...
Eric Olson
Shape plays an important role in fine particles in many ways. For instance, the correlation between specific surface area and pharmaceutical dissolution is well documented and governed by Fick’s first law of diffusion (1-3). Aside from a decrease in particle size and an increase in particle porosity, the other major way of increasing the specific...
David Markovitz
In manufacturing, problems occur that must be fixed. Conducting a careful analysis during the problem solving process can lead to problem prevention. This is where the real rewards are. In US Food and Drug Administration-regulated industries, a process called corrective action and preventive action (CAPA) exists to address problem solving and...
Validation Week 2021


Validated Cloud logo