B.Gowry Snehitha, B.Charu Hasini, A.Divya, K.Aaradhana, A.Revathi, Dr.I.V.Ramarao
Quality by Design is the modern approach for quality of pharmaceuticals. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design. 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. Also it includes a short view over the application of Various QbD tools like PAT, CAPA and HACCP in Pharmaceutical industry along with their importance in the Quality aspect of Pharmaceutical products. It also tries to cover the major aspects to be concerned while selecting the wide ranges of designs and statistical toolswhile employing QbD to a Particular aspect of Pharmaceutical Technology.
Article Details
Unique Paper ID: 162032

Publication Volume & Issue: Volume 10, Issue 7

Page(s): 450 - 456
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