Validation Standard Operating Procedures

ISBN: 9780849395291

出版社: Taylor & Francis

出版年: 2006-5

页数: 1144

定价: $ 271.14

装帧: HRD

内容简介

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.