Quality by Design

  • Posted on: 1 December 2015
  • By: admin

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PharmaTutor (December- 2015)


Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 3, Issue 12)


Received On: 06/06/2015; Accepted On: 16/08/2015; Published On: 01/12/2015


AUTHORS: Chaudhary Sonam*, Rathore KS
Department of Pharmaceutics
Bhupal Noble’s Institute of Pharmaceutical Sciences, Udaipur, Rajasthan, India


ABSTRACT: A new approach to drug development could increase efficiencies, provide regulatory relief, flexibility, and offer important business benefits throughout the product’s life cycle. Quality by design is a systemic approach and essential part of the modern approach for quality and pharmaceutical development.

It includes defining target product quality profile, designing product, developing formulations, manufacturing processes, identifying critical quality attributes,  process parameters, sources of variability and controlling manufacturing processes to ensure consistent  product quality over time.

Pharmaceutical quality can be assured by understanding, controlling formulation and manufacturing variables using Quality by design. Product quality can be confirmed by product testing. Pharmaceutical industry have to  work hard to develop, manufacture, to bring  new drugs to market, to comply with regulatory requirements to ensure  that the drugs are safe and effective. Implementation of Quality by design leads to transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.


How to cite this article: S Chaudhary, KS Rathore; Quality by Design; PharmaTutor; 2015; 3(12); 23-28