Abstract
GLP Essentials—A Concise Guide to Good Laboratory Practice provides the reader with a brief yet adequate introduction to good laboratory practices (GLPs). The book is divided into six chapters, with the first three chapters providing a historical perspective of the GLP concept and a description of undesirable laboratory practices discovered by governmental surveillance, which prompted the need to develop and implement US and international GLP regulations. The remaining three chapters cover the basic elements of managing a scientific study applying GLPs from the construction of study plan or protocol, performance and reporting of study to monitoring for compliance. Chapter 5 describes the use of standard operating procedures and general responsibilities of a quality assurance unit (QAU) in monitoring regulated studies. This chapter also includes examples of documents typically maintained by a QAU such as a study inspection report, master schedule record, and a quality assurance unit statement that is typically included in regulated study reports. Each document is supported in the text by a description and how it is used. The last 22 pages of the book provide useful reference material such as a glossary of terms as defined in the GLP regulations and internet resources such as the OECD and FDA website addresses as well as addresses for several professional scientific societies. The book has no index, however, because of the simple formatting and small number of pages (only 59 pages of chapter text); the book is easily searchable.
This book is useful for scientists interested in a historical background of GLPs and particularly beneficial to those who are involved or will be involved in conducting studies that conform to GLPs.