Description

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

More Details about Validation of Pharmaceutical Processes 3e

General Information  
Author(s)Agalloco
PublisherInforma Healthcare
Edition3
ISBN9780849370557
Pages737
BindingHard Back
LanguageEnglish
Publish YearJanuary 2008