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Quality by Design and Process Analytical Technology: Important Tools for Buliding Quality in Pharmaceutical Products

Volume 2 - Issue 1

Ashrani Sunil*1, Goyal Anju2 and Vaishnav Rajat2

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    • 1M Pharma Research Scholar, Bhupal Nobles’ University, India
    • 2Department of Pharmaceutical Quality Assurance, Bhupal Nobles’ University, India

    *Corresponding author: Sunil Ashrani, M. Pharma Research Scholar, Bhupal Nobles’ University, Sewashram Choraya, Udaipur, Rajastan, India

Received: January 18, 2018;   Published: January 30, 2018

DOI: 10.26717/BJSTR.2018.02.000704

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ICH Q8 guideline defines Quality by Design as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. The QbD based approaches provides a high degree of assurance that pharmaceutical manufacturing process is adjustable within a design space and hence the process is robust and managed with a control strategy developed using modern statistical process control methods. It enables a lifecycle approach to validation/continuous process verification. The building of Quality into the manufacturing products at its design stage is very important to reduce expenditure, time & energy. Also the market recall of products due to batch failure is reduced to minimum with the use of QbD. PAT is also related to QbD. It refers to Process analytical technology. PAT has been defined as “A system for designing, analyzing, and controlling manufacturing through measurements, during processing of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality”. The present paper deals on these two terms QbD and PAT.

Key words: Quality by Design; PAT; Design Stage; ICH Q8

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