Pharmaceutical Quality Assurance: Principles and Practices

By Prof V Girija Sastry, Dr N Siva Kumar, MS Y Achyutha Valli Devi

Book Overview

A Comprehensive Guide to Ensuring Pharmaceutical Quality and Compliance

This book, "Pharmaceutical Quality Assurance: Principles and Practices," provides an in-depth exploration of the key principles, methodologies, and regulatory frameworks that govern pharmaceutical quality.

✦ Covering Essential Topics, Including:

✔ Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

✔ Regulatory Guidelines (ICH, USFDA, WHO, EMA, ISO 9000, NABL Accreditation)

✔ Quality by Design (QbD) and Risk Management in Pharmaceuticals

✔ Validation, Calibration, and Analytical Method Validation

✔ Pharmaceutical Documentation, Complaints Handling, and Product Recalls

• Format: Paperback
• Language: English
• ISBN: B0DXVWV7FW
• ISBN13: 9798897248162
• Release Date: February 2025
• Publisher: Notion Press
• Length: 260 Pages
• Weight: 1.04 lbs.
• Dimensions: 0.7" x 6.0" x 9.0"