Optimizing Pharmaceutical Analysis: A Comprehensive Guide

Authored by Kim Huynh-Ba, this book provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience. It presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines.

Pharmaceutical Regulations and Quality Systems

The book focuses on smaller molecular weight drug substances and products, providing the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. It covers the structure, roles, core guidelines, and GMP regulations of the FDA and ICH, as well as control strategies established from quality systems supported by real-world case studies.

Pharmaceutical Analysis Methodologies

Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. The book describes the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs.

Control Strategies and Quality Control

It examines control strategies established from quality systems supported by real-world case studies. The book explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. It also discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance.

Practical Applications and Resources

The book includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. It contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals.

Education and Training

It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs. This comprehensive guide is essential for those looking to enhance their knowledge and skills in pharmaceutical analysis and GMP compliance.