JVT Journal Articles
Vol. 20, Issue 3, Oct 2014

Paul L. Pluta, Ph.D.
Cliff Campbell, B.E., is Principal, Cliff Campbell Consulting, Ltd., Cork, Ireland. Mr. Campbell is a globally recognized expert in process validation. He and Paula Katz (FDA) recently published “Process Validation Revisited” in the Journal of Validation Technology in Q4 2012. This paper received the JVT “Paper of the Year” award in 2013 and is...
Tim Sandle
The effective control and management of documentation is a critical part of the GMP program within the organization. Documentation control is not optional – it is a legal requirement. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
William V. Collentro
"Analytical Monitoring of Compendial Water Purification Systems" discusses chemical and microbial monitoring within the water purification system producing compendial water to a storage and distribution system, feed water to a distillation unit, or feed water to a Pure Steam Generator.
FDA published Process Validation: General Principles and Practices in 2011. This guidance significantly changed the process validation paradigm for pharmaceutical products. Industry faces significant challenges in implementing this guidance. Ideas and suggestions to be considered for implementation are described. Implementation requires an...
Jane Weitzel
Measurement Uncertainty is an essential component of the analytical Quality by Design approach to an analytical procedure. Measurement uncertainty is defined as the non-negative parameter characterizing the dispersion of the quantity values being attributed. Measurement uncertainty has important critical ramifications in use and interpretation of...
John E. Lincoln
Common definition challenges during the medical device lifecycle are addressed. Working definitions for respective validation and verification activities must be developed to clarify activities and expectations. Validation typically describes the overallactivity tied to customer requirements. Verification is a subset of validation including...
Siegfried Schmitt
Data integrity is a prerequisite for the regulated healthcare industry. Electronic data and computerized systems have introduced new challenges to maintaining data integrity. Main criteria for data integrity are provided. Major regulatory guidelines are referenced. Key areas of focus are identified. Relevant Warning Letter and FDA-483 citations...
Traditional validation processes are not efficient and cost effective. These deficiencies are caused by excessive document reviews and approvals, duplicate roles and responsibilities, inconsistent practices, institutional silos, and other problems. These negatively impact project timelines, increase costs, and cause non-value-added work. Potential...