Abstract

REVIEW ON ANALYTICAL QUALITY BY DESIGN AND PAT

Payal Chauhan*, Dhruvi Modi, Mansuri Seemabanu, Savitree Giri, Anjali Rathod, Khushbu K. Patel and Dr. C. N. Patel

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Abstract

Quality by design is the modern approach for quality by design. the basic concept of QBD is the quality cannot by tested the product. it describe quality elements of quality of pharmaceuticals the quality target product profile, critical attributes identified for each unit benefits, ability and steps involved in quality by design in this review quality risk management describe systemic method for examination regulation, validation and knowledgment and validation of the threats of the quality of the finished products risk assessment also provide fishbone diagram. It also gives composition between tradition analytical method development between QBD analytical method development, in this review various parameters of validation to give best product. the objective of this review article is to provide a various aspect of QBD.

Keywords: AQbD (Analytical quality by design), Process analytical technology (PAT), DOE (design of experiment), MODR (method operation range).