Quality Risk Management (Q9): An Overview
Journal Title: International Journal of Pharmaceutical and Medicinal Reserach - Year 2014, Vol 2, Issue 2
Abstract
The goal of the CGMPs for the 21st Century initiative such as advancing science and technological innovation. Update guidance based on regulatory experience since 1987. Quality Risk management emphasizes on risk management and maintaining quality during commercialization. Quality Risk management also emphasizes the role of objective measures and statistical tools & analyses and emphasizes knowledge, detection and control of variability and gives assurance on consistent of quality/productivity throughout life cycle of product.
Authors and Affiliations
Abhishek Maithani, Kumar Gaurav
Keywords
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