Thomas P. Layloff, Ph.D.

The views expressed here are those of the author or those to whom the materials are attributed
and not necessarily those of past or current employers and associates.

Dr. Layloff is currently Senior Quality Assurance Advisor for the Supply Chain Management System (SCMS, pfscm.org), “President’s Emergency Plan for AIDS Relief.” He is on sabbatical from his permanent position as Principal Program Associate for Pharmaceutical Quality in the Center for Pharmaceutical Management, Management Sciences for Health (msh.org) assisting in pharmaceutical quality issues in international commerce and developing nations. He also is a Special Government Employee to the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) as a member of the Manufacturing Advisory Sub-Committee and Past-Chair of the Pharmaceutical Analytical Technology (PAT) Sub-Committee. These committees are advisory to CDER in the development of a guidance documents which will address the incorporation of new technologies into the approval and inspection processes.

Prior to joining MSH he was employed by the United States Pharmacopeia (USP) as Vice-President and Director of the Pharmaceutical Division (Rockville, MD). He also previously served in CDER as Associate Director for Standards Development (Rockville, MD) and for over 20 years as the Director of FDA’s leading pharmaceutical testing laboratory in St. Louis, MO. He was elected to serve two-five year terms on the USP Committee of Revision where he was a member of two Chemistry Revision Sub-Committees, Chair of the General Chapters Sub-Committee, member of the Reference Standards Committee, and member of the Division of Standards Development Executive Committee (policy-setting body for USP standards) and it’s Chair. He is very active in the FDA and California Separation Science Society jointly sponsored WCBP (formerly the Well-Characterized Biotechnology Pharmaceuticals) symposium series where he served as Co-Chair of the 2001, 2002, 2003 and 2004 meetings, and member and past-Chair of the Permanent Organizing Committee (www.casss.org ). He is Past-President and elected Fellow of AOAC International, and elected Fellow of the American Association of Pharmaceutical Scientists. He is a member of Sigma Xi and Phi Lambda Upsilon honor societies. He received BA/BS degrees in Chemistry and an MS in Organic Chemistry from Washington University (St. Louis, MO), and a Ph.D. in Analytical Chemistry from the University of Kansas (Lawrence).

Food and Drug Administration
(FDA) St. Louis pharmaceutical laboratory, 1967-1994

Drug Dissolution Testing

Tanzania SEAM QA Project

Compendium of Thin Layer Chromatography Methods

Publications of Interest

Leadership

Meandering Thoughts

About Me

This page was established to share materials of interest. Some documents, such as the Executive Summaries of the St. Louis FDA laboratory, are public domain; they were distributed to visitors and other individuals interested in the laboratory’s activities. All other materials were submitted for publication or presented in public meetings and forums.

Thanks are due to the publishers of “Pharmaceutical Technology,” “Pharmacopeial Forum,” and “American Genomic/Proteomic Technology” for permission to reprint papers which they originally published.

Tim Grady’s Corner

My good friend and former USP colleague Tim Grady and I frequently challenged each other and wrote articles addressing positions as the USP evolved new standards. Some of these articles were never published and the web now
offers an easy outlet to make them available. Tim wrote the articles and I agreed to set aside a section on my webpage to make them publicly available.

These articles present Tim’s views which may not be those of the USP or me but getting them out there may stir some thoughts and that is good.

I hope you enjoy his articles and I’m sure there will be others.

Recent Updates:

2016 NOV 16 - Roxithromycin method added.
2016 Nov 07 - Famotidine TLC method added.
2016 Oct 20 - Gentamicin Detection modification added

Footnotes:


Last updated 2016 September. Questions or comments concerning this web site should be sent to tom@layloff.net.