Analytical Testing for the Pharmaceutical GMP Laboratory

Analytical Testing for the Pharmaceutical GMP Laboratory is a comprehensive guide to pharmaceutical analysis, covering regulations, processes, and best practices. It provides practical guidance for establishing a compliant laboratory and covers topics such as drug regulations, analytical methodologies, control strategies, testing development, and validation. The book is written by leading experts with extensive industry experience and is a valuable resource for pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals.

Format: Hardback
Length: 416 pages
Publication date: 12 April 2022
Publisher: John Wiley and Sons Ltd

Analytical Testing for the Pharmaceutical GMP Laboratory is a comprehensive guide that provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience. The book offers a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing a pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations.

Concise yet comprehensive chapters cover up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource:

Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH.

Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs.

Examines control strategies established from quality systems supported by real-world case studies.

Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers.

Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance.

In conclusion, Analytical Testing for the Pharmaceutical GMP Laboratory is an essential resource for anyone involved in pharmaceutical analysis, quality control, or drug development. With its comprehensive coverage of regulatory requirements, analytical methodologies, and best practices, the book equips readers with the knowledge and skills necessary to ensure the quality and safety of pharmaceutical products.

Weight: 718g
Dimension: 259 x 142 x 28 (mm)
ISBN-13: 9781119120919