Validation of Pharmaceutical Processes, Third Edition

Reflecting significant advances in pharmaceutical production and regulatory expectations, this Third Edition blueprints every step of the validation process needed to remain compliant and competitive. The chapters added to the prior edition examine:validation and six sigma system design
• preparation of aseptic and non-aseptic products
• active pharmaceutical ingredient and biotechnology processes, computerized systems
• qualification and cleaning of equipment
• analytical methods, calibration, and certification. This expanded edition analyzes fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.