Pharmaceutical Quality Assessment System (PQAS): Science and Risk Managed Approaches for Inhalation Drug Products
Poochikian G, Shah V.
Respiratory Drug Delivery 2006. Volume 1, 2006: 151-158.
Abstract:
This article describes a newly established pharmaceutical quality assessment system (PQAS) developed by the Office of New Drug Quality Assessment (ONDQA), formerly known as the Office of New Drug Chemistry (ONDC) within the FDA. This system is being implemented under the FDA’s major initiative, “Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach”. The article further discusses some key components of the quality by design (QbD) concept that is envisioned for a successful development, manufacture, and quality control of the drug products.
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