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Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by
design (QbD) principles for in-depth process understanding to ensure that product quality is built in by
design.The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe
how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality
should be built in by design.
Under this concept of QbD throughout designing and development of a product, it is essential to define
desire product performance profile [Target product profile (TPP), Target product Quality profile(TPQP)
and identify Critical quality attributed (CQA). On the basis of this we can design the product formulation
and the process to meet the product attributes. These leads to recognize the impact of raw material
[Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification
and source of variability.The application of the concept of quality by design (QbD) presented in this
paper aligns with the principles of ICH Q8, Q9 and Q10 guidelines.
Key words: Quality by Design (QbD), Quality target product profile (QTPP), Critical process parameter
(CPP), critical quality attribute (CQA), Target product profile (TPP), and Critical material attributes
(CMA).