Optimizing Pharmaceutical Analysis: A Comprehensive Guide

Authored by Kim Huynh-Ba, this comprehensive guide provides practical insights into pharmaceutical analysis, leveraging the extensive industry experience of leading experts. It offers a thorough overview of pharmaceutical regulations, working processes, and drug development best practices aimed at maintaining the quality and integrity of medicines.

Pharmaceutical Regulations and GMP Compliance

The book delves into the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. It emphasizes the importance of establishing a pharmaceutical laboratory that supports Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations.

Pharmaceutical Analysis Methodologies

It covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. These methodologies are crucial for ensuring the efficacy and safety of pharmaceutical products.

Control Strategies and Quality Systems

The guide examines control strategies established from quality systems, supported by real-world case studies. This section is particularly useful for professionals looking to implement effective quality control measures in their pharmaceutical laboratories.

Dissolution Testing and Product Development

Describing the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers, the book provides valuable insights into the development and manufacturing of pharmaceutical drug products.

Good Documentation and Data Reporting Practices

It explains the importance of good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance with regulatory requirements.

Practical Applications and Templates

Containing practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs), this guide is an indispensable resource for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals.

Training and Education

It serves as a valuable 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.