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Country Of Origin : India
The primary goal of this book is to provide master of pharmacy students with up-to-date knowledge of various quality assurance data, as well as the skills necessary to develop methods for a variety of drug combinations. Special emphasis is placed on modern techniques like SUPAC and PAT, as well as a thorough explanation of ISO, GMP, and ICH guidelines.
Contents
01. Basic Terminology Used In Quality Assurance 02. Total Quality Management 03. ISO 9001 : 2000 04. Environmental Management Systems and ISO 14000 05. GMP and GMP Compliance 06. Master Formula Record 07. Good Documentation Practices 08. Validation 09. Statistical Methods Used For Method Development 10. Analytical Method Development for Pharmaceutical Formulations 11. Guidelines on Audit Quality 12. ICH Harmonised Tripartite Guideline for Pharmaceutical Quality System