Essential Elements for a GMP Analytical Chemistry Department / Edition 1

by Thomas Catalano

Overview

Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP’s, regulatory guidance’s/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies. ​

Product Details

ISBN-13:	9781461476412
Publisher:	Springer New York
Publication date:	06/21/2013
Edition description:	2013
Pages:	195
Product dimensions:	6.10(w) x 9.25(h) x 0.03(d)

About the Author

Dr. Tom Catalano’s has 30 years in the Pharmaceutical Industry in various positions including the Global Director of Analytical R&D, with major companies such as G.D. Searle, Pharmacia and Pfizer, which led to a multitude of experience in providing analytical support to dosage forms and drug substances including biologicals. Additionally, he worked for a biopharmaceutical company, Theravance, as Sr. Director of Technical Operations.

He provided analytical support to a variety of dosage forms and drug substances, which included:

Tablets, Soft Capsules, Hard Capsules, Creams and Gels Injectables (Suspensions, Solutions or Lyophilized) Controlled Release Forms (Oral and Injectable) Manufacture of small molecules, peptides and proteins

In Dr. Catalano’s 30 years in the industry, he made significant contributions to the development and registration of many products such as NutraSweet, Cytotec, Arthrotec, Celebrex, Bextra, Dynastat, Inspra and Vibativ (glycopeptide antibiotic).

Currently Dr. Catalano is president of a consulting company, PharmChem Analytical Consultants LLC.

Table of Contents

Introduction.- Organization.- Department Structure.- Project Teams.- Responsibilities.- Interactions.- Operating Guidance’s.- Processes.- Safety.- Technology.- Department.- Statistical Concepts for the Analytical Chemist.- Data distribution.- Significance Testing.- Confidence Intervals.- Outliers in analytical data.- Regression.- Experimental design.- Required sample replicates.- Method performance.- Uncertainty measurement.- Sampling strategies.- Outsourcing.- Process.- Audit Check List.- Documentation.- Sample Submission.- Technical Report.- Reports of analysis.- Records (Training etc.).- Job Descriptions.- Career Tracks.- Motivating Personnel.- Career Path.- Hiring the Best.