The Journal of GXP Compliance
Vol. 17, Issue 4, Nov 2013

In this presentation from IVT's 19th Annual Validation Week, Paul Pluta, Ph.D., discusses applying the lifecycle approach to the validation quality system. The validation business system; the processes and equipment to be validated; the validation and qualification initiation responsibility; risk management; and design, performance, and review quality system metrics are examined in the first part of the session.
William R. Porter
Current approaches to estimation of batch shelf life for pharmaceutical products are not satisfactory. An alternative approach, based upon measuring shelf life directly, can be used in conjunction with an expanded Arrhenius model to predict shelf life under unstressed conditions based upon shelf life measured under stressed conditions. Such an...
Timothy J. Fields
The term “GxP” is becoming a more commonly used acronym in the pharmaceutical and biopharmaceutical industries whereupon “x” serves as a variable for a variety of terms; some based on regulations and some on regulatory expectations as defined in guidance documents. Some of the more common uses of “x” include good manufacturing practices (GMPs),...
David Barr
For a number of years, US Food and Drug Administration warning letters and FDA 483s have frequently listed problems with pharmaceutical manufacturers’ quality systems, especially failure investigations and corrective actions. The most recent FDA statistics on current good manufacturing (cGMP) observations lists inadequate investigations of batch...
Gordon Welty, Ph.D.
This paper is the first of two parts that discuss the development of a train-the-trainer (TTT) program for regulatory compliance.
Gordon Welty, Ph.D.
This paper is the second of two parts that discuss the development of a train-the-trainer (TTT) program for regulatory compliance. This part focuses on the content of such a TTT program. It addresses the various topics that are presented in the classroom session in greater detail.
Eugenie Webster (Khlebnikova)
This paper discusses the application of American National Standards Institute (ANSI)/American Society for Quality (ASQ) Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes. It provides simple instructions on how to correctly select the sampling plan based on the population size and the acceptable risk. In addition, this paper...
Michael H. Anisfeld
The need for a single worldwide accepted Pharmacopoeia (compendium of drug quality standards) has been recognized for about 150 years when work first started in 1874 on developing the International Pharmacopoeia. This harmonization work, started over a century ago, ultimately resulted in the World Health Organization’s (WHO) publication, The...
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