Description

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

More Details about Validation of Pharmaceutical Processes Sterile Products 2e

General Information  
Author(s)Carleton
PublisherRoutledge Taylor and Francis group
Edition2
ISBN9780824793845
Pages856
LanguageEnglish
Publish YearJanuary 2012