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. Presenting theoretical knowledge and applied practical considerations, this title provides an in-depth discussion of recent advances in sterilization identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutionsISO 14644-1 Part 1: classification of air cleanliness; ISO 14644-2: specifications for testing and monitoring to prove continued compliance with ISO 14644-1; ISO/ FDIS 14644-3 Part 3: test methods; ISO ... European Standard EN 1822-1.
|Title||:||Validation of Pharmaceutical Processes, Third Edition|
|Author||:||James P. Agalloco, Frederick J. Carleton|
|Publisher||:||CRC Press - 2007-09-25|