Equipment Qualification in the Pharmaceutical Industry (Paperback)

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

General

Imprint:	Academic Press Inc
Country of origin:	United States
Series:	Aspects of Pharmaceutical Manufacturing
Release date:	June 2019
First published:	2019
Authors:	Steven Ostrove
Dimensions:	229 x 152 x 19mm (L x W x T)
Format:	Paperback
Pages:	234
ISBN-13:	978-0-12-817568-2
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Business & Economics > Business & management > Management of specific areas > Production & quality control management Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Physics > Applied physics & special topics > Biophysics Books > Science & Mathematics > Chemistry > Organic chemistry > General Books > Science & Mathematics > Biology, life sciences > Biochemistry > General
LSN:	0-12-817568-0
Barcode:	9780128175682

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