A Review on Process Variables Effects of an Oral Dosage Form by Using “Quality by Design”

Abstract

Quality by design is an important tool which used by pharmaceutical manufacturer with increased self-regulated flexibility while maintaining best quality standards and fast production of the product. The concept of QBD was mentioned in the ICH Q8 guidance, which elaborate that “quality cannot be tested into products, i.e., quality should be built in by design”. Under the concept of QbD during designing and development of a product, a company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA).This paper discuss about the pharmaceutical quality by design and describes how it can be used to study the effect of process parameters on quality attributes of oral dosage forms.