GXP Journal Articles
Vol. 17, Issue 1, Feb 2013

In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on the historical perspective and current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. They highlight...
David Markovitz
Developing effective written procedures is a challenging task. There are three primary impediments to developing effective procedures. These include differences in education, language, and age between authors of the procedures and the employees who will be using the procedures. Remedies for each of these gaps are proposed. Addressing these three...
Joseph Busfield
Equipment and instrumentation in facilities governed by current good manufacturing practices (cGMPs) must remain in a validated/qualified state. The site calibration program is a critical part of this effort. Requirements for equipment are stated in Code of Federal Regulations (CFR) Title 21 Part 211.68. General elements of a site calibration...
Michael Gietl
Cleaning residue limits for cleaning validation must be determined based on scientific and technical principles. Fourman and Mullen established the foundation for what has become the standard industry approach to setting limits for residual actives (1). They proposed that equipment be visually clean, that there be no more than 1/1000th of a daily...
Alan Schwartz
Both good manufacturing practice (GMP) and International Organization for Standardization (ISO) are quality systems. However, there are differences between quality system regulation (QSR)/current good manufacturing practice (cGMP) compliance and ISO certification. The GMPs are a regulatory requirement mandated by law. ISO is a voluntary...
Steven S. Kuwahara
In these discussions, the US Food and Drug Administration Compliance Program Guidance Manual (CPGM) for good laboratory practices (GLPs) has been reviewed to provide the reader with information on topics that may be addressed during a GLP inspection. In addition, the Guidance Manual, available online at the US Food and Drug Administration website...
Michael H. Anisfeld
Without question the need for staff training is an essential element to attain quality and, as such, is a GMP prerequisite in every GMP code worldwide.
Madhu Raju Saghee
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Tim Sandle
This paper examines the process of gamma irradiation of plastic materials used as part of single-use disposable systems in the pharmaceutical and biotechnology sectors, with a focus on validation requirements. Single-use disposable systems are designed to be sterile and are primarily used for aseptic processing, formulation, filtration, and...
Michael H. Anisfeld
It is estimated that China manufactures about 80% of the active pharmaceutical ingredients (APIs) imported into the United States and the European Union (EU) for use in the manufacture of finished dosage forms. China is the consumer of over 95% of the finished dosage forms manufactured in the country with most of these dosage units manufactured in...
James Kaar
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Patrick Klemens
A quality audit is an important tool for any business to employ. When effectively used as an internal audit, the business will gain greater understanding of its compliance to applicable regulations and internal requirements. Further, the business can critically evaluate the suitability of its procedures and the health of the relationships within...
Jerry Lanese, Ph.D.
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Timothy J. Fields
This column is one of a continuing series in which representatives of the industry and regulatory agencies have an opportunity to express their opinions on current GXP issues.