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A Review on Quality by Design (QbD)

  • Unique Paper ID: 167864
  • Volume: 11
  • Issue: 4
  • PageNo: 616-625
  • Abstract:
  • In this Review, we have done extensive literature on Quality by Design. ICH guidelines Q8 (pharmaceutical development), Q9 (quality risk management) and Q10 (quality systems) forms the basis of QbD. QbD defines the quality target product profile (QTPP), critical quality attributes (CQA), risk assessment and life cycle management to design and develops the formulation and process. This review provides overview of the modern pharmaceutical quality by design (QbD), clarifies the concept and describes its objectives. It is a cost and time efficient approach in design and manufacturing, with DoE, risk assessment, and PAT as its tools to achieve a better understanding on the materials and processes, which make the QbD approach available and feasible to the pharmaceutical field. It also gives application of Quality by Design in pharmaceutical development and manufacturing of pharmaceuticals.
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Cite This Article

  • ISSN: 2349-6002
  • Volume: 11
  • Issue: 4
  • PageNo: 616-625

A Review on Quality by Design (QbD)

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