The Journal of GXP Compliance
Vol. 16, Issue 1, Jan 2012

This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders. A three-tiered approach is described. This paper also discusses the application of engineering and procedural controls in pharmaceutical manufacturing. Practical examples to cover a variety of pharmaceutical dosage forms are included to illustrate this comprehensive approach.
Scott Sutton, Ph.D.
Most microbiologists would claim that the recorded numbers of colony forming units (CFU) were raw data. This is not correct. That recorded number is someone’s (presumably a skilled technician’s) interpretation of the number of colonies on the plate. Experience has shown that different technicians (each skilled) can, and frequently do, come up with...
Amy Sabin
Since 2005, both global regulatory agencies and industry have been touting the benefits of QbD. “Improved process knowledge,” “robust tech transfer,” and “regulatory flexibility” are phrases that have been heard at many industry seminars and conferences over the last six years. These are often soon followed by “How do I implement that?” and “Is...
Amy Sabin
Given the wide range of particle sizing technologies and instrumentation on the market, the choice of measurement technique can be daunting, especially if one is unfamiliar with the options available. Once introduced and familiar with an individual technique, it can be easy to continue to choose it by default. While this is certainly...
Tim Sandle
The pharmacopeial standard applying to sterile products is that sterile products must be capable of passing a test for sterility. The sterility test is an important microbiological test in terms of regulatory expectation rather than probability of detecting gross contamination. It allows for the examination of products purportedly to be sterile....
David Markovitz
Internal audits are a useful tool in maintaining an effective quality system. Internal GXP audits often reveal gaps and inconsistencies in systems and processes. Conducting internal audits is a valuable training exercise and prepares an organization for audits by an external agency.
Lynn Torbeck
“Compliance Tools” discusses the various techniques and methods used by quality and compliance professionals in their daily work responsibilities. We intend this column to be a resource for daily work applications.
James Kaar
Patrick Klemens
Welcome to the second 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.
Jennifer Carlson
“Cleaning Compliance Forum” discusses scientific principles, strategies, and approaches associated with cleaning that are useful to practitioners in compliance and validation. We intend this column to be a valuable resource for daily work applications.
Jerry Lanese
Timothy J. Fields
“GXP Talk” discusses issues identified by readers of the journal and provides current good practice to resolve those issues. We encourage readers to ask questions about compliance issues that are challenging to their firms or to industry. We also encourage readers to respond with opinions as to how to resolve the question or issues presented,...
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