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QUALITY BY DESIGN (QBD): A QUALITY IMPROVEMENT PERSPECTIVE FOR PHARMACEUTICAL DEVELOPMENT

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2013

Key Words:

Author Name
Abstract (2. Language): 
Quality by design (QbD) is a new modern perspective towards the qualitative pharmaceutical development. This is a systemic approach to design and development of the pharmaceutical formulations and manufacturing processes that ensures the predefined product quality. This QbD consists the chain of elements which on execution gives the consistent quality over time. Implementation of QbD enables the assurance of pharmaceutical quality by understanding and controlling formulation and manufacturing variables. Quality risk management (QRM) serves the base for control strategy, which is only can attain by process understanding. This new paradigm of drug development provides relief from regulatory framework that imparts flexibility, increase in efficiency by offering important benefits by business point of view throughout the product's life cycle. Continual improvement can be achieve by QbD implementation as it is systematic way of product and process development.
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REFERENCES

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ISSN: 2277-8713
IJPRBS
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