Analytical Method Validation: QbD

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.

CAROLYN M. MERKEL is the Founding Partner of Mariner Analytical LLC. She earned her BS in Chemistry from Ramapo College of New Jersey; PhD at Columbia University (Inorganic Chemistry, thesis advisor Dr. Stephen J. Lippard), and an additional MS in Technology Management at New Jersey Institute of Technology. She was a Robert A. Welch Fellow at the University of Texas at Arlington (advisor Dr. Donald R. Martin). In her business career, she focused on beverages, food, and nutritional products. After almost 20 years with global consumer product companies, she formed Mariner Analytical LLC. Mariner Analytical provides full-service technical support to a diverse roster of clients, ranging from start-ups to Fortune 50 companies. She consults domestically and internationally on projects ranging from chemical manufacturing and medical devices to dietary supplements and snack foods. She applies her passion for Quality - developed with rigorous training and excellent mentorship - to practice a multidisciplinary approach to problem-solving.She is a Certified Food Scientist, and a member of Sigma Xi, the American Chemical Society, and the Institute of Food Technologists. She has numerous patents and publications, is an accomplished public speaker, and has received awards for teaching and research as well as community service. She believes passionately in education, with active membership in the Ramapo College Alumni Association, currently serving as President, and is honored to be a member of the Ramapo College Board of Governors.