QBD: A NEW ERA OF PHARMACEUTICAL DRUG DEVELOPMENT
Divyesh Sharma*, Khushbu Patel and Dr. C. N. Patel
Quality by design (QbD) is a critical component of today's pharmaceutical quality advancements. QbD is the most effective way to ensure that all pharmaceutical products are of high quality. This paper discusses Pharmaceutical Quality by Design (QbD) and how it can be used to ensure the quality of pharmaceutical analysis. It is critical to define desired product output report under this definition of being in the design and growth of the product. Identify important quality attributes and establish a target product profile (TPP) and a quality target product profile (QTPP). To understand how raw material critical material attributes (CAM) and critical process parameters (CPP) affect CQAs, as well as to identify and monitor sources of changeability. The ICH Guidelines are the cornerstone of Quality by Design. It is based on the International Conference on Harmonization (ICH) Guidelines Q8 for pharmaceutical production, Q9 for quality risk management, and Q10 for pharmaceutical quality systems.
Keywords: Quality by design, Pharmaceutical Analysis, Critical Quality Attributes, Risk Assessment, Design of Experiment Regulatory.
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