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A Review on:Quality by Design (QbD)


Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, India
3 MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, India
     

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Quality by Design is the modern approach for quality of pharmaceuticals. 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 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. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)

Keywords

Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).
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  • A Review on:Quality by Design (QbD)

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Authors

Vrushali R. Kadam
Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
M. P. Patil
Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India
Vrushali V. Pawar
Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, India
Sanjay Kshirsagar
MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, India

Abstract


Quality by Design is the modern approach for quality of pharmaceuticals. 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 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. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)

Keywords


Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).

References