Analytical Testing for the Pharmaceutical GMP Laboratory


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ISBN: 9781119120919 Category:

<p><i>Analytical Chemistry: An Introduction to the Pharmaceutical GMP Laboratory</i> 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.</p> <p>Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource:</p> <ul> <li>Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH.</li> <li>Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs.</li> <li>Examines control strategies established from quality systems supported by real-world case studies.</li> <li>Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers.</li> <li>Discusses good documentation and data reporting practices, stability pr</li> <li>Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations.</li> </ul>