Quality Assurance Techniques in Pharmaceuticals

V.M.Waghulkar Thakare (Author), K.K. Tapar (Author), V.N. Shrikhande (Author)

9789381450130

Hardback, published 15 January 2012

298 pages
25 x 15 x 1.5 cm, 0.69 kg

In this era of quality assurance, it is imperative that every organization strives for quality in order to achieve its objectives. This book has been prepared with the aim of providing basic techniques, methods, plans, and certification procedures for quality assurance, with the syllabus laid out by various Indian universities in mind. 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.

• 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