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
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Prof. V. Girija Sastry, Dr. N. Siva Kumar, Ms. Y. Achyutha Valli Devi
Prof. Girija Sastry Vedula
Professor,
A.U. College of Pharmaceutical Sciences,
Andhra University,
Visakhapatnam, Andhra Pradesh, India
Dr. Siva Kumar Nemala
Associate Professor,
Sri Vasavi Institute of Pharmaceutical Sciences,
Pedatadepalli, Tadepalligudem,
West Godavari (Dist.), Andhra Pradesh, India
Ms. Achyutha Valli Devi Yerra
Research Scholar,
A.U. College of Pharmaceutical Sciences,
Andhra University,
Visakhapatnam, Andhra Pradesh, India
