European Journal of Chemistry 2017, 8(4), 430-433 | doi: https://doi.org/10.5155/eurjchem.8.4.430-433.1667 | Get rights and content






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


Selda Dogan Calhan (1,*) , Ebru Derici Eker (2) , Nefise Ozlen Sahin (3)

(1) Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey
(2) Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey
(3) Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Mersin University, 33169, Mersin, Turkey
(*) Corresponding Author

Received: 01 Nov 2017 | Revised: 14 Nov 2017 | Accepted: 14 Nov 2017 | Published: 31 Dec 2017 | Issue Date: December 2017

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.


Keywords


Drug; Spectroscopy; Quality by design; Product development; Pharmaceutical industry; Process analytical technology

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DOI: 10.5155/eurjchem.8.4.430-433.1667

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[1]. Valentina D’Atri, Szabolcs Fekete, Adrian Clarke, Jean-Luc Veuthey, Davy Guillarme
Recent Advances in Chromatography for Pharmaceutical Analysis
Analytical Chemistry  91(1), 210, 2019
DOI: 10.1021/acs.analchem.8b05026
/


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

How to cite


Calhan, S.; Eker, E.; Sahin, N. Eur. J. Chem. 2017, 8(4), 430-433. doi:10.5155/eurjchem.8.4.430-433.1667
Calhan, S.; Eker, E.; Sahin, N. Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry. Eur. J. Chem. 2017, 8(4), 430-433. doi:10.5155/eurjchem.8.4.430-433.1667
Calhan, S., Eker, E., & Sahin, N. (2017). Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry. European Journal of Chemistry, 8(4), 430-433. doi:10.5155/eurjchem.8.4.430-433.1667
Calhan, Selda, Ebru Derici Eker, & Nefise Ozlen Sahin. "Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry." European Journal of Chemistry [Online], 8.4 (2017): 430-433. Web. 22 Sep. 2020
Calhan, Selda, Eker, Ebru, AND Sahin, Nefise. "Quality by design (QbD) and process analytical technology (PAT) applications in pharmaceutical industry" European Journal of Chemistry [Online], Volume 8 Number 4 (31 December 2017)

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DOI Link: https://doi.org/10.5155/eurjchem.8.4.430-433.1667

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