Cargando…
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...
Autores principales: | , , , , |
---|---|
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 |
_version_ | 1782448803031285760 |
---|---|
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. |
format | Online Article Text |
id | pubmed-4991121 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT pramodkannissery pharmaceuticalproductdevelopmentaqualitybydesignapproach AT tahirmabu pharmaceuticalproductdevelopmentaqualitybydesignapproach AT charoonaseema pharmaceuticalproductdevelopmentaqualitybydesignapproach AT ansarishahidh pharmaceuticalproductdevelopmentaqualitybydesignapproach AT alijaved pharmaceuticalproductdevelopmentaqualitybydesignapproach |