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Pharmaceutical product development: A quality by design approach

The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applica...

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Autores principales: Pramod, Kannissery, Tahir, M. Abu, Charoo, Naseem A., Ansari, Shahid H., Ali, Javed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991121/
https://www.ncbi.nlm.nih.gov/pubmed/27606256
http://dx.doi.org/10.4103/2230-973X.187350
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author Pramod, Kannissery
Tahir, M. Abu
Charoo, Naseem A.
Ansari, Shahid H.
Ali, Javed
author_facet Pramod, Kannissery
Tahir, M. Abu
Charoo, Naseem A.
Ansari, Shahid H.
Ali, Javed
author_sort Pramod, Kannissery
collection PubMed
description The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.
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spelling pubmed-49911212016-09-07 Pharmaceutical product development: A quality by design approach Pramod, Kannissery Tahir, M. Abu Charoo, Naseem A. Ansari, Shahid H. Ali, Javed Int J Pharm Investig Review Article The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. Medknow Publications & Media Pvt Ltd 2016 /pmc/articles/PMC4991121/ /pubmed/27606256 http://dx.doi.org/10.4103/2230-973X.187350 Text en Copyright: © International Journal of Pharmaceutical Investigation http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Review Article
Pramod, Kannissery
Tahir, M. Abu
Charoo, Naseem A.
Ansari, Shahid H.
Ali, Javed
Pharmaceutical product development: A quality by design approach
title Pharmaceutical product development: A quality by design approach
title_full Pharmaceutical product development: A quality by design approach
title_fullStr Pharmaceutical product development: A quality by design approach
title_full_unstemmed Pharmaceutical product development: A quality by design approach
title_short Pharmaceutical product development: A quality by design approach
title_sort pharmaceutical product development: a quality by design approach
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4991121/
https://www.ncbi.nlm.nih.gov/pubmed/27606256
http://dx.doi.org/10.4103/2230-973X.187350
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