Full Description
In the current climate of quality assurance, it is essential for every organization to ensure that it meets its quality objectives. The book under consideration has been prepared with this goal in mind, focusing on the fundamental techniques, methods, plans, and certification procedures for quality assurance, while taking into account the syllabus for quality assurance techniques outlined by various Indian universities. The aim of this publication is to provide both basic and updated information on a range of quality assurance data to students pursuing a professional program in pharmacy. The book specifically covers statistical methods utilized in method development, with a focus on modern techniques like SUPAC and PAT, as well as providing a comprehensive explanation of ISO, GMP, and ICH guidelines.
Contents
1. Basic Terminology Used In Quality Assurance
2. Total Quality Management
3. ISO 9001 : 2000
4. Environmental Management Systems and ISO 14000
5. GMP and GMP Compliance
6. Master Formula Record
7. Good Documentation Practices
8. Validation
9. 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
