European Journal of Chemistry

Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry

Article Sidebar

PDF
Published: Dec 31, 2017
DOI: https://doi.org/10.5155/eurjchem.8.4.430-433.1667
Keywords:
Drug, Spectroscopy, Quality by design, Product development, Pharmaceutical industry, Process analytical technology
Section
Review Article
Issue
Vol. 8 No. 4 (2017): December 2017
Dates
Received 2017-11-01
Accepted 2017-11-14
Published 2017-12-31


Main Article Content

Selda Dogan Calhan
Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey
Ebru Derici Eker
Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey
Nefise Ozlen Sahin
Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey

Abstract

Quality by Design (QbD) for the pharmaceutical industry includes the design, development and production control of products and production processes from the beginning to the end of the product development phase for ensuring the consistent quality of a pharmaceutical product. The QbD is a systematic scientific approach aimed at meeting the needs of the patient in the desired and targeted quality and aiming to produce the same quality pharmaceutical product in this direction. Process Analytical Technology, which is assessed in that regard, is part of a design quality approach that is used to design, analyze, and control real-time measurements of quality and performance criteria for raw and processed materials to achieve the desired final product. This scientific and systematic approach to pharmaceutical product development, which is also acknowledged and supported by the health authorities, serves to the changing and developing pharmaceutical sector.


icon graph This Abstract was viewed 2940 times | icon graph Article PDF downloaded 1110 times

How to Cite
(1)
Calhan, S. D.; Eker, E. D.; Sahin, N. O. Quality by Design (QbD) and Process Analytical Technology (PAT) Applications in Pharmaceutical Industry. Eur. J. Chem. 2017, 8, 430-433.

Article Details

Share
Links for Article


Crossref - Scopus - Google - European PMC
Crossref
Scopus
Google Scholar
Europe PMC
References

[1]. Mike, F.; Bozdag, P. S.; Oner, L. Hacettepe Univ. J. Fac. Pharm. 2013, 33(2), 203-230.

[2]. Turkey Pharmaceutical Sector Vision 2023 Report Strategy Document, Association of Research-Based Pharmaceutical Companies. 2012, pp. 23-27.

[3]. DeMatas, M.; DeBeer, T.; Folestad, S.; Ketolainen, J.; Linden, H.; Lopes, J. A.; Oostra, W.; Weimer, M.; Ohrngren, P.; Rantanen, J. Eur. J. Pharm. Sci. 2016, 90, 2-7.
https://doi.org/10.1016/j.ejps.2016.04.024

[4]. Raman, N. V. V. S. S.; Mallu, U. R.; Bapatu, H. R. J. Chem. 2015, 2015, 1-8, ID: 435129.

[5]. Politis, S. N.; Colombo, P.; Colombo, G.; Rekkas, D. M. Drug Dev. Ind. Pharm. 2017, 43(6), 889-901.
https://doi.org/10.1080/03639045.2017.1291672

[6]. Rantanen, J.; Khinast, J. J. Pharm. Sci. 2015, 104(11), 3612-3638.
https://doi.org/10.1002/jps.24594

[7]. Burggraeve, A.; Monteyne, T.; Vervaet, C.; Remon, J. P.; Beer, T. Eur. J. Pharm. Biopharm. 2013, 83(1), 2-15.
https://doi.org/10.1016/j.ejpb.2012.09.008

[8]. Ferreira, A. P.; Tobyn, M. Pharm. Dev. Technol. 2015, 20(5), 513-527.
https://doi.org/10.3109/10837450.2014.898656

[9]. Pramod, K.; Tahir, M. A.; Charoo, N.; Ansari, S.; Ali, H. Int. J. Pharm. Investig. 2016, 6(3), 129-138.
https://doi.org/10.4103/2230-973X.187350

[10]. Rathore, A. S.; Bhambure, R.; Ghare, V. Anal. Bioanal. Chem. 2010, 398(1), 137-154.
https://doi.org/10.1007/s00216-010-3781-x

[11]. Haleem, R. M.; Salem, M. Y.; Fatahallah, F. A.; Abdelfattah, L. E. Saudi Pharm. J. 2015, 23(5), 463-469.
https://doi.org/10.1016/j.jsps.2013.11.004

[12]. Aksu, B.; Beer, T.; Folestad, S.; Ketolainen, J.; Linden, H.; Lopes, J. A.; Matas, M.; Oostra, W.; Rantanen, J.; Weimer, M. Eur. J. Pharm. Sci. 2012, 47(2), 402-405.
https://doi.org/10.1016/j.ejps.2012.06.009

[13]. FDA, Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, 2004.

[14]. Zhang, L.; Mao, S. Asian J. Pharm. Sci. (AJPS) 2017, 12(1), 1-8.

[15]. Peres, D. D.; Ariede, M. B.; Candido, T. M.; Almeida, T. S.; Lourenco, F. R.; Consiglieri, V. O.; Kaneko, T. M.; Velasco, M. V. R.; Baby, A. R. Drug Dev. Ind. Pharm. 2017, 43(2), 246-256.
https://doi.org/10.1080/03639045.2016.1236809

[16]. Naidu, V. R.; Deshpande, R. S.; Syed, M. R.; Deoghare, P.; Singh, D.; Wakte, P. S. AAPS Pharm. Sci. Tech. 2017, 18(6), 2045-2054.
https://doi.org/10.1208/s12249-016-0680-2

[17]. Hertrampf, A.; Muller, H.; Menezes, J. C.; Herdling, T. J. Pharm. Biomed. Anal. 2015, 114, 208-215.
https://doi.org/10.1016/j.jpba.2015.05.012

[18]. Chavez, P. F.; Lebrun, P.; Sacre, P. Y.; Bleye, C.; Netchacovitch, L.; Cuypers, S.; Mantanus, J.; Motte, H.; Schubert, M.; Evrard, B.; Hubert, P.; Ziemons, E. Int. J. Pharm. 2015, 486, 13-20.
https://doi.org/10.1016/j.ijpharm.2015.03.025

[19]. Warnecke, S.; Rinnan, A.; Alleso, M.; Engelsen, S. B. Appl. Spectrosc. 2015, 69(3), 323-331.
https://doi.org/10.1366/14-07470

[20]. Yan, B.; Chen, T.; Xu, Z.; Qu, H. J. Pharm. Biomed. Anal. 2014, 94, 116-110.
https://doi.org/10.1016/j.jpba.2014.01.033

[21]. Jin, Y.; Wu, Z.; Liu, X.; Wu, Y. J. Pharm. Biomed. Anal. 2013, 77, 32-39.
https://doi.org/10.1016/j.jpba.2013.01.012

[22]. Simone, E.; Zhang, W.; Nagy, Z. K. J. Chem. Technol. Biotechnol. 2016, 91, 1461-1470.
https://doi.org/10.1002/jctb.4743

[23]. Kim, D. W.; Park, J. B.; Lee, S. H.; Weon, K. Y. J. Drug Delivery Sci. Technol. 2017, 39, 8-15.
https://doi.org/10.1016/j.jddst.2017.02.008

[24]. Rosas, J. G.; Blanco, M.; Gonzalez, J. M.; Alcala, M. Talanta 2012, 97, 163-170.
https://doi.org/10.1016/j.talanta.2012.04.012

[25]. Wu, Y.; Jin, Y.; Li, Y.; Sun, D.; Liu, X.; Chen, Y. Vib. Spectrosc. 2012, 58, 109-118.
https://doi.org/10.1016/j.vibspec.2011.10.006

Supporting Agencies

Most read articles by the same author(s)

Most read articles by the same author(s)

TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution, or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).