Analytical Testing for the Pharmaceutical GMP Laboratory

by Kim Huynh-Ba

Unlock expert guidance on pharmaceutical analysis with this authoritative resource by Kim Huynh-Ba, crafted by leading industry professionals with extensive expertise. This comprehensive book delivers an in-depth exploration of pharmaceutical regulations, operational processes, and drug development best practices to ensure medicine quality and integrity, emphasizing small molecular weight drug substances and products. It equips readers with essential knowledge to establish GMP-compliant laboratories while adhering to Good Manufacturing Practices (GMP) standards.

Featuring concise yet thorough chapters, it covers FDA and ICH regulations, analytical methodologies, control strategies, method development, validation, transfer, and electronic data documentation. The book includes real-world case studies, dissolution testing for extended-release capsules, aerosols, and inhalers, stability programs, and Laboratory Information Management Systems (LIMS). Enhanced with tables, figures, calculations, and SOP templates, it supports daily laboratory operations and training.

Key Features

• Detailed coverage of pharmaceutical regulations and analytical techniques
• Real-world case studies and quality system control strategies
• Practical SOP templates, calculations, and illustrations for lab processes
• Essential for pharmaceutical scientists, analytical chemists, and GMP training