Analytical Testing For The Pharmaceutical GMP Laboratory (EPUB)
Written by Kim Huynh-Ba
offers helpful advice on pharmacological analysis authored by eminent professionals with a wealth of knowledge in the field.
The comprehensive overview of pharmaceutical laws, operational procedures, and best practices for drug development that are
employed to preserve the purity and quality of medications is provided by Analytical Testing for the Pharmaceutical GMP Laboratory.
The book offers the information required for setting up a pharmaceutical laboratory to support Quality Systems and adhere to
Good Manufacturing Practices (GMP) laws, with an emphasis on lower molecular weight medicinal ingredients and products.
Up-to-date information on drug legislation, pharmaceutical analysis methodology, control strategies, testing development and
validation, method transfer, electronic data documentation and more is covered in concise yet thorough chapters.
A table of contents, acronym definitions, a reference list and several tables and figures are included in every chapter.
This reputable site discusses the main tasks and legal issues associated with analytical testing in the creation and production
of pharmaceutical medicinal products.
outlines the GMP regulations, key guidelines, duties, and organizational structure of the ICH and FDA.
includes examples of analytical procedures used for drug release and stability testing, as well as a discussion of common analytical
technology utilized in pharmaceutical laboratories.
investigates control tactics developed from quality systems and backed by case studies from the actual world. explains the application
of dissolution testing to goods including inhalers, aerosols, and extended-release capsules.
explains stability programs, the Laboratory Information Management System (LIMS) and appropriate documentation and data
reporting techniques in order to maintain compliance.
In order to help readers with day-to-day laboratory activities, this section includes calculations, application examples, and pictures.
Provides useful information and templates for organizing standard operating procedures (SOPs) or internal operations.
Pharmaceutical scientists, analytical chemists, pharmacists and quality control specialists in their early and advanced careers
should all own Analytical Testing for the Pharmaceutical GMP Laboratory.
It is also a great textbook for analytical chemistry courses taken at the undergraduate and graduate levels in the pharmaceutical
sciences or in regulatory compliance programs.
It is a resource for GMP laboratory training programs.
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