A brief review on Quality by Design [QbD] a Systematic Approach

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Rinkal M. Bhadra , Dr. Shailesh V. Luhar, Dr. Sachin B. Narkhede

Abstract: Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. Now-a-days the concept of QbD can be extended to analytical techniques. In this concept of QbD it is essential to define desire product performance profile, analytical target Profile and identify critical quality attributes throughout designing and development of a process. This review aimed to identify implementation of QbD in analytical procedure validation. The purpose of analytical QbD is to attain quality in measurement. it describes a multifactorial optimization of 4critical  HPLC method parameters, i.e. gradient time(tG), temperature(T), pH and ternary composition (B1:B2) based on experiments. .The basic element is a gradient time temperature (tGT) plane, which is repeated at   three   different pH’s of the eluent A and at three different ternary compositions of eluent B between methanol and acetonitrile.”

Keywords: QbD, HPLC, Pharmaceutical development (Q8), quality risk management (Q9)

QbD, HPLC, Pharmaceutical development (Q8), quality risk management (Q9)