In the name of Allah the Merciful

Analytical Testing for the Pharmaceutical GMP Laboratory

Kim Huynh-Ba, 1119120918, 9781119120919, 978-1119120919

English | 2022 | PDF

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Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience

Analytical  Testing for the Pharmaceutical GMP Laboratory presents 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  the pharmaceutical laboratory to support Quality Systems while  maintaining compliance with Good Manufacturing Practices (GMP)  regulations.

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. 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.Includes calculations, application  examples, and illustrations to assist readers in day-to-day laboratory  operations.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. 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.