This book contains essays on data integrity.
Data integrity is the most basic element of work in any scientific discipline.
Nothing of lasting value in the hard sciences (physics, chemistry, biology,
astronomy, et al.) lacks integrity in the data used to support the premises,
the logical arguments proposed, and the conclusions drawn. The point of
validation is, after all, to ensure that all results obtained and reported are
true.
The original premise of our book was to merge the global standard for
pharmaceutical analytical methods for regulatory applications [ICH
Q2(R1)] with contemporary thinking on ensuring data quality by
thoroughly understanding a method and its intended application (QbD).
During a preproduction meeting, an incisive question led to expanding the
scope of the original five chapters: "Can this be applied to fields other than
pharmaceuticals?" The answer was: Yes.
Three chapters were added to explore the applications of Quality by Design
theory to real world problems that are bound not only by regulations, but by
business constraints, professional ethics, time, resources, and technology. They
may serve as case studies for classes of advanced students.
The scientific approach is rigorous, drawing on, and integrating, classical wet
and modern instrumental analytical chemistry knowledge. The reasoning is
detailed and well-documented. Examples are carefully explained. Two are
based on historical events. The other is a problem that is not yet fully resolved
despite its importance and significant risks to human health globally.
The tone throughout is conversational. It is intended to involve students -
and any reader who has a vested interest in data integrity, which includes the
global scientific communities from academia, industry, and government, and
producers and consumers of quantitative measurements and the goods and
services obtained by their use.
The objective is to impart an intuitive understanding of method validation:
planning, execution, and documentation,
with examples of practices and
problems, and with practical strategies for addressing both.
A special feature is the inclusion of "Hints" - brief comments offering
experience-based advice acquired while developing, validating, reviewing, and
auditing analytical methods (and data) in a variety of industries
and countries.
LAWRENCE A. WILSON is a Managing Partner of Mariner Analytical LLC. He received undergraduate degrees in Chemistry (BS) and Psychology (BA) from the State University of New York at Oswego, MS in Medicinal Chemistry from Stevens Institute of Technology (with Dr. Ajay K. Bose and Dr. M.S. Manhas), and MBA in Marketing and Management from Fairleigh Dickinson University (thesis: Mathematical Tools for Decision Quality Enhancement). He studied Applied Chemistry at the University of Texas at Arlington on the D.Sc. track and mentored doctoral candidates in a then-novel, work-study program in his research laboratory. He has worked in diverse industries, including: fine chemical manufacturing, heavy industries [mining, building materials (cement, gypsum, roofing, glass), paper], flavors and fragrances, pharmaceuticals, pesticides, polymers (and more) at the laboratory bench, led global Teams, managed research and manufacturing facilities, contributed to multiple marketing applications for successful drugs, and advised on policy - in particular, organizational redesign to accelerate product development. Over the last two decades, he has consulted domestically and globally - chiefly within the pharmaceutical industry - at research, manufacturing/ packaging, and clinical trial sites, with a consistent focus on ensuring data integrity and data quality.
