The Journal of GXP Compliance
Vol. 18, Issue 4, Dec 2014

Jerry Lanese and Timothy J. Fields, editors
A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance and the Current Good Practice for Resolution of the Issues. This column is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to ask questions about, and express opinions on, current GXP issues....
Jerry Lanese
The Journal of GXP Compliance is pleased to present “Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification.” This paper was authored by the USP Validation and Verification Expert Panel and was published in USP Pharmacoepeal Forum (39) 6, 2013.
In this Stimuli article, the USP Validation and Verification Expert Panel discusses how the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures. The Expert Panel proposes that the traditional approaches to validation, transfer, and...
Tim Sandle
Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The paper discusses staff gowning and personnel behavior in pharmaceutical cleanrooms, and how cleanroom risk can be minimized. The human skin ecosystem is discussed.
Steven C. Schumann
A small molecule pharmaceutical company received multiple field complaints describing the presence of yellow discoloration observed on a commercially marketed, white, film-coated tablet. This report describes the investigation to identify the root cause and the subsequent corrective action.
William R. Porter
Photodegradation is discussed from both scientific and regulatory perspectives. The need for a range of experimental studies is emphasized, beginning in the earliest phase of new drug product development.
Richard C. Wedlich
Agata E. Libera
Joseph M. Fransen
T. Heath
Matthew T. Therrien
All of us engage in risk management on the job, whether we call it so or not. We frequently plan and set priorities. We understand there are serious consequences of missing a deadline and that often the reason is because project timelines were unrealistic or affected by something not under our control. A program utilizing QbD principles for...
Carol Brandt
A robust pharmaceutical complaint handling system can hold the answer to product or process problems, root cause of a failure, enhancement needed to quality systems, or be an early warning sign for avoidable recalls. This paper describes key aspects of a customer complaint system and the process of addressing complaints in compliance with...
Paul L. Pluta
Large group training (10-30 people) is a specialized category of training activity. This discussion describes a novel method to initiate large group training sessions. The approach uses a short true-false test to be presented to all attendees at the start of the training session
Paul L. Pluta
This discussion addresses problems and potential problem-solving approaches associated with sampling, sample results, and original data. Sampling problems may have very significant consequences. When there are problems with sampling, there likely are problems with results. Original data associated with sampling and test results must be...
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