Validating Pharmaceutical Systems

Validating pharmaceutical systems; good computer practice in life science manufacturing.

Ed. by John Andrews.

Taylor & Francis

2006

549 pages

$249.95

Hardcover

RS122

Andrews, an experienced engineer in pharmaceuticals, compiles 20 essays and a glossary by an international group of contributors in the pharmaceutical industry. They discuss automated systems validation and regulations for drug development, production, and distribution; and they analyze the inspection, risk assessment and management, planning, reporting, auditing, specifications, documentation, testing, and calibration of validations systems. In addition, the authors explain GCP, GLP See gateway location protocol. , and GMP GMP (guanosine monophosphate): see guanine.
..... Click the link for more information. regulatory requirements, manufacturing education systems (MES (Manufacturing Execution Software) Software that provides real time access to plant activities that include equipment, labor, orders and inventory. An MES integrates the data with enterprise resource planning (ERP) systems so that management has complete control of ), and include case studies of SCADA (System Control and Data Acquisition) systems, the LIMS system (Laboratory Information Management System), GAMP 4 (Good Automated Manufacturing Practice Good Automated Manufacturing Practice (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE). The goal of the committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical ), and validation in Central and Eastern Europe The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90.
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