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

Indu Bala, Suraj Verma, Kuldeep Namdev


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.


quality by design, ICH Q8, Target Product Profile (TPP), Target Product Quality Profile (TPQP), critical quality attributed (CQA).

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DOI: https://doi.org/10.25258/ijddt.v5i1.8863


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