The Journal of GXP Compliance
Vol. 16, Issue 3, Aug 2012

Dissolution testing is a vital quality control test. It is a regulatory requirement for essentially every regulated non-solution dosage form in commercial distribution. Dissolution testing methods are complex procedures that include details that may significantly impact test results if not carefully executed. Compliance personnel must be knowledgeable of dissolution testing methods as well as problems that may contribute to...
Dijana Hadziselimovic
Paul Lopolito
Carbomers are crosslinked high molecular weight polymers of acrylic acid, often called Carbopols (Carbopol is a registered trademark of Lubrizol former Noveon, Incorporated). Due to their unique characteristics, they are used in the manufacturing of pharmaceutical products including oral dosage forms, cosmetics and personal care products, topicals...
David Markovitz
Good written procedures are vital to success in regulated industries. There are many reasons that employees do not follow written procedures. Many of these reasons relate to the quality of the writing. Characteristics, preparation, and implementation of well-written procedures are discussed. Preparing good written procedures is critical for...
Harry Yang
In August 2002, United States Food and Drug Administration announced a new initiative, Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century (1).
Steven S. Kuwahara
This discussion begins a series on the US Food and Drug Administration Compliance Program Guidance for GLPs. It provides the reader with information on the topics that may be addressed during a GLP inspection. In addition, the guidance manual available online at the FDA website is a useful guidance for workers who are new to conducting audits of...
Eric Olson
Since the introduction of quality by design and design space in ICH Q8 (1), it has been apparent that US Food and Drug Administration and the rest of the international regulatory community expect pharmaceutical dosage form developers to establish a thorough, science-based knowledge of its product and processes, and present this knowledge in its ­...
James Kaar
Patrick Klemens
Welcome to the fourth article in the series “The Business of Auditing and Auditing the Business.” This article continues to explore the elements of the quality audit (including the emotional components) as we see how an experienced quality professional in a changing business manages an evolving audit situation.
Alice Krumenaker
“ASQ CPGP Basics” discusses various good manufacturing practice (GMP) topics from the American Society for Quality (ASQ) Body of Knowledge for the Certified Pharmaceutical GMP Professional (CPGP) program. We intend this column to provide basic theory and application of GMP topics useful to quality professionals and be a valuable resource for daily...
Kristin Jarrell
Elixir Sulfanilamide was an antibiotic drug product available in 1937. Its formulation caused more than 100 deaths in 15 states. Many of these deaths were children. This catastrophe increased public awareness of the potential dangers with drugs. Responding to a shocked nation, congress passed the 1938 Food, Drug, and Cosmetic Act, which...
Jerry Lanese
Timothy J. Fields
This article is a continuing series in which representatives of the industry and the regulatory agencies have an opportunity to express opinions on current GXP issues. Thank you for your responses to questions 50 and 51 posed in the Spring 2012 issue of the Journal of GXP Compliance. The questions are repeated below together with responses.
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