Authors : Sachin L. Darkunde
DOI : 10.18231/2394-2797.2018.0001
Volume : 5
Issue : 1
Year : 0
Page No : 1-6
Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. Quality has been given an importance by all regulatory body for pharmaceutical products. Quality means customer satisfaction in terms of service, products, and process. QbD is best key to build a quality in all pharmaceutical products. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceutical Analysis. Under this concepts of be throughout design and growth of product, it is important to identify desire product performance report Target product profile (TPP), Quality Target product profile (QTPP) and identify critical quality attributes (CQA). To recognize the impact of raw material critical material attributes (CAM), critical process parameters (CPP) on the CQAs and identification and control sources of changeability. USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD. QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products. In the present review basic consideration of the QbD approach, its historical background, and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent, design of experiment, and risk assessment is given. The foundation of Quality by Design is ICH Guidelines. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.
Keywords: Quality by design, Critical Quality Attributes, Pharmaceutical Analysis, Design Of Experiment, Risk Assessment, Regulatory.