Volume No. :   7

Issue No. :  4

Year :  2017

ISSN Print :  2231-5640

ISSN Online :  2231-5659


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A Review on: Quality by Design (QbD)



Address:   Vrushali R. Kadam1*, Dr. M. P. Patil1, Vrushali V. Pawar2, Dr. Sanjay Kshirsagar3
1Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, India.
2Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, India.
3Principal of MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, India.
*Corresponding Author
DOI No: 10.5958/2231-5659.2017.00030.3

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).
Cite:
Vrushali R. Kadam, M. P. Patil, Vrushali V. Pawar, Sanjay Kshirsagar. A Review on: Quality by Design (QbD). Asian J. Res. Pharm. Sci. 2017; 7(4):197-204.
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