Validation of Pharmaceutical Processes, Third Edition, provides a comprehensive overview of the principles, methodologies, and regulatory requirements involved in the validation of pharmaceutical manufacturing processes. The book explains how validation programs are designed and implemented to ensure that facilities, equipment, utility systems, analytical methods, computerized systems, and manufacturing operations consistently produce products that meet predefined quality, safety, and efficacy standards. It covers key aspects of process validation, including qualification of support and utility systems, sterilization and sanitization procedures, sterility assurance, aseptic processing, sterile product manufacturing, primary and secondary production operations, laboratory methods, and computerized systems. The text also addresses documentation practices, process performance verification, risk management, contamination control, cleanroom operations, and quality assurance requirements in accordance with current Good Manufacturing Practices (GMP). Supported by practical examples and industrial case studies, the book serves as an essential reference for pharmaceutical scientists, validation specialists, quality assurance professionals, regulatory personnel, and manufacturing engineers involved in pharmaceutical and biotechnology production.

Ngôn ngữ:	eng
Tác giả:	Agalloco, James, Carleton, Frederick J.
Thông tin nhan đề:	Validation of Pharmaceutical Processes
Nhà xuất bản:	Informa Healthcare USA, Inc.
Loại hình:	Giáo trình sách, tham khảo / Bộ sưu tập: Công nghệ Hóa
Mô tả vật lý:	737p.
Năm xuất bản:	2007