Approach of analytical quality by design and regulatory need
Keywords:
Quality, Regulation, ICH, Robustness, Risk managementAbstract
This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. Quality cannot be tested into products but quality should be built in by design. The concept of QbD can be extended to analytical methods. The emphasis of AQbD approach is on understanding of the operation and the variables affecting Analytical Methods employed in product development. The variables which affect the output are identified and subjected to thorough risk assessment employing various tools and techniques discussed in the article, after which the variables are optimized. The final method is validated and a control strategy is put in place. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design). ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products.
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