The Journal of Validation Technology
Vol. 20, Issue 4, Jan 2015

Jerry Lanese
The Journal of Validation Technology 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...
Anne Greene
Kelly Waldron
Nuala Calnan
This paper summarizes research designed to characterize the current state of pharmaceutical and biotechnology industries with respect to the adoption of Quality Risk Management as per ICH Q9. The research supports the hypotheses that the full value of QRM with respect to product quality and patient safety has not yet been realized. In addition,...
The FDA guidance described three stages in the lifecycle approach including Process Design, Process Qualification, and Continued Process Verification (CPV). The CPV stage of the lifecycle approach is the final stage, which continues throughout the entire commercial life of the product process—it never ends. Continuous Process Verification is an...
Jane Weitzel
Robert A. Forbes
Ronald D. Snee
In this paper, we illustrate the application of the lifecycle management approach for an analytical procedure (a drug substance potency test) and showed how a decision rule is used to develop the analytical target profile (ATP).
John E. Lincoln
Knowing which QMS is operable, under what circumstances, and in which markets, is critical to compliance and to the accuracy of subsequent documentation in meeting regulatory requirements. Understanding that though ISO 13485 and 21 CFR 820 QMS requirements have many similarities, they are different documents with different requirements and...
Agata E. Libera
Joseph M. Fransen
Matthew T. Therrien
Richard C. Wedlich
T. Heath
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...
Ivan Soto
The execution of computer validation protocol requires a comprehensive program with a document hierarchy to support the process. System assessments are critical inputs to the system specifications and computer validation protocols. Writing computer validation protocols require adequate system specifications and the completion of the system...
Paul L. Pluta
The validation initiation document is a key document. It officially begins the validation. It likely will be the first document to be audited, reviewed, or otherwise consulted when the validation project is in progress. When the “how” component of the initiation, i.e., risk analysis and validation plan, is included in the initiation, it sets the...
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