Quality by Design: A Roadmap for Quality Pharmaceutical Products

Mayur Ashok Chordiya; Hemant Hiraman Gangurde; Vikram Nirmal Sancheti

doi:10.4103/jrptps.jrptps_2_18

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https://doi.org/10.4103/jrptps.jrptps_2_18

Quality by Design: A Roadmap for Quality Pharmaceutical Products

Author(s):

Mayur Ashok Chordiya^1,*,

Hemant Hiraman Gangurde¹,

Vikram Nirmal Sancheti²

1Department of Pharmaceutics, SNJB's Shriman Sureshdada Jain College of Pharmacy, Nashik, India

2Department of Pharmaceutics, Rajarshi Shahu College of Pharmacy, Buldana, Maharashtra, India

Journal of Reports in Pharmaceutical Sciences:Vol. 8, issue 2; 289-94

Published online:Dec 31, 2019

Article type:Systematic Review

How to Cite:Mayur Ashok ChordiyaHemant Hiraman GangurdeVikram Nirmal SanchetiQuality by Design: A Roadmap for Quality Pharmaceutical Products.J Rep Pharm Sci.8(2):e147415.https://doi.org/10.4103/jrptps.jrptps_2_18.

Abstract

Quality by design (QbD) refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product life cycle. QbD is increasingly becoming an important and widely used technique in the pharmaceutical industry. QbD can be considered to be system‑based approach to the design, development, and delivery of any product or service to a consumer. It is an approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities, and steps involved in QbD of pharmaceutical products are described. The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products, but quality should be built in by design. It includes the quality target product profile, critical quality attributes, and key aspects of QbD. It also gives comparison between product quality by end product testing and product quality by QbD. The foundation of QbD is ICH guidelines. Hence, if we identify the cause and effect relationship between the various inputs and responses by carefully designed experiments, we can control the quality of the product by simply controlling the inputs such as raw material specifications or process parameters.

Keywords

Critical Quality Attributes

pharmaceutical manufacturing

process analytical technology

Quality by Design

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Author(s):

Mayur Ashok Chordiya:[PubMed][Scholar]
Hemant Hiraman Gangurde:[PubMed][Scholar]
Vikram Nirmal Sancheti:[PubMed][Scholar]