Pharmaceutical Quality Assurance: Principles and Practices
| AUTHOR | MS Y Achyutha Valli Devi; Dr N Siva Kumar; Prof V Girija Sastry |
| PUBLISHER | Notion Press (02/17/2025) |
| PRODUCT TYPE | Hardcover (Hardcover) |
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
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