Written By Torbeck, Lynn and Torbeck, Joyce
2015, Edition 1
Category: Quality Control
Level: Introductory
Davis Healthcare International
United States of America
URL: http://www.DHIBooks.com
About This Book
This book is for pharmaceutical professionals working in product discovery, development, manufacturing, quality assurance and quality control. It presents a basic introduction to data and Trend and Out-of-Trend definitions, and proposes terminology to clarify the use of the word "control" in several contexts. Outtakes from FDA warning letters, plant audits and investigations for trend and out of trend are presented to highlight the agency's viewpoint. Helpful graphs, charts and tables are also included throughout the book and in the appendices.
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