Publisher's Synopsis
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