A review on quality by design
Journal Title: International Journal of Pharmaceutical Chemistry and Analysis - Year 2018, Vol 5, Issue 1
Abstract
Quality by design QbD is an essential part of the modern advance to pharmaceutical quality Quality has been given an importance by all regulatory body for pharmaceutical products Quality means customer satisfaction in terms of service products and process QbD is best key to build a quality in all pharmaceutical products This paper gives idea about the Pharmaceutical Quality by Design QbD and describes use of Quality by Design to ensure quality of Pharmaceutical Analysis Under this concepts of be throughout design and growth of product it is important to identify desire product performance report Target product profile TPP Quality Target product profile QTPP and identify critical quality attributes CQA To recognize the impact of raw material critical material attributes CAM critical process parameters CPP on the CQAs and identification and control sources of changeability USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submit chemistry manufacturing and controls CMC of NDA information representing application of QbD QbD has its perspectives to contribute the drug design development and manufacture of highquality drug products In the present review basic consideration of the QbD approach its historical background and regulatory needs are discussed In detail explanation of elements of QbD ie method intent design of experiment and risk assessment is given The foundation of Quality by Design is ICH Guidelines It is based on the ICH Guidelines Q8 for pharmaceutical development Q9 for quality risk management Q10 for pharmaceutical quality systems It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticalsKeywords Quality by design Critical Quality Attributes Pharmaceutical Analysis Design Of Experiment Risk Assessment Regulatorynbsp
Authors and Affiliations
Sachin L. Darkunde
Keywords
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- EP ID EP481419
- DOI 10.18231/2394-2797.2018.0001
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