2. Quality by Design is the modern approach for quality of pharmaceuticals.
This paper gives idea about the Pharmaceutical Quality by design (Qbd)
and describes use of Quality by Design to ensure quality of Pharmaceutic
The aim of the pharmaceutics development is to design Quality product
and its manufacturing process to consistently deliver the intended
performance of the product
QbD (Quality by design) was one of the design experiment approved
by The FDA to maintain the quality of the drug products before
reaching to the market
ABSTRACT
Keywords: Quality by design (QbD), current Good Manufacturing Practices
(cGMP), Design of Experiments (DoE),
quality, FDA, pharmaceutical products
3. . The aim of pharmaceutical development is to design a
quality product and its manufacturing process to
consistently deliver the intended performance of the Product
QbD is a systematic approach that helps in the Development
Of the pharmaceutical products by improving the quality
Quality by design (QbD) is a concept first
invented by the quality scientist Dr. Joseph M. Juran
Woodcock defined a highquality drug product as a product that
should be free From contamination and reliably delivering the
therapeutic response promised in the label to the Consume
INTRODUCTION
4. AIM:-
OBJECTIVE :-
To Understanding pharmaceuticals Quality By Design
The main objective of QbD is to achieve the quality products
To achieve positive performance testing.
Ensures combination of product and process knowledge
gained during development
From knowledge of data process desired attributes may be
constructed.
5. Nishendu P. Nadpara* et al no 2012 :
Literature review
Quality by Design is the modern approach for quality of
pharmaceuticals.
The aim of the pharmaceutical development is to design a
quality product and its manufacturing process to consistently
deliver the intended performance of the Product
Mr. Shrikant M. Mohurle
the FDA launches the current Good Manufacturing Practices
(cGMP), which was an approach without understanding the
processes. So FDA decided to applied the several Design of
Experiments (DOE) in the pharmaceutical fields.
6. REFERENCE
1. Woodcock J, The concept of pharmaceutical quality.
American Pharmaceutical Review, 7(6), 2004, 10–15
Quality Risk Management. ICH Harmonized Tripartite
Guidelines. International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals
for Human Use, 2006.
3. Q10: Pharmaceutical Quality System, ICH Tripartite
Guidelines. International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals
for Human Use, 2007.
