European Journal of Chemistry

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

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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.


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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.

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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

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