AN OVERVIEW OF TECHNOLOGY TRANSFER AS A REGULATORY ASPECT

  • G. M. PAVITHRA Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, SRIHER (DU), Porur, Chennai 600116
  • MANORANJITH Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, SRIHER (DU), Porur, Chennai 600116
  • S. NAGALAKSHMI Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, SRIHER (DU), Porur, Chennai 600116

Abstract

Technology Transfer is fundamental and crucial to the drug development process for new drug products. The great decision is based on that factor in which the concept or process is advanced from research and development-oriented scheme to aimed towards the commercialization of the drug. The transfer could also be said to achieve success if the receiving section and the transferee can efficiently use the technology for profit. The achievement relies upon an understanding of the process or the capability to predict exactly the future prospects of a process. The main intention of this review article is to study the Regulatory aspects of technology transfer. This review article is mainly focused on the Consequence of technology transfer, the purpose for technology transfer in industries, barriers concerned with technology transfer, classification regarding technology transfer, facets of technology transfer, and steps among technology transferThis review was carried out by systematic searches of data integrity in relevant ICH, WHO, and US guidelines, published articles, reviews and abstracts in Google scholar, Pubmed, Science direct, Embase, Web of science of articles up to 2020.

Keywords: Technology transfer, Pharmaceutical industry, WHO guidelines on technology transfer, ICH guidelines

References

1. Ramanathan K. An overview of technology transfer and technology transfer models. Available from: http://tto.boun.edu.tr/files/1383812118_An%20overview%20of%20TT%20and%20TT%20Models.pdf. [Last accessed on 03 Oct 2020]
2. Allamneni Y, Chary PD, Kumar SC, Rao VB. Technology transfer process in pharmaceutical industry: an overview | PharmaTutor; 2020. Available from: https://www.pharmatutor.org/articles/overview-of-technology-transfer-in-pharmaceutical-industry. [Last accessed on 03 Oct 2020]
3. Talokar SS, Vakhariya RR. Technology a buzz word in pharma world. Asian JPharm Sci 2017;7:18-22.
4. Amneet K, Sharma OP, Jatinder D. Technology transfer in pharmaceutical industry. Int J Curr Pharm Res 2013;5:16-8.
5. Bhusan B, Nautiyal U, Kumar S, Bakar A. Technology transfer in pharmaceutical industry: a review. Int J Pharm Med Res 2014;2:94-9.
6. Rani SS, Rao BM, Ramaro P, Kumar S. Technology transfer-models and mechanism. Int J Mech Eng Technol 2018;9:971-82.
7. John RM. Technology transfer in pharmaceutical industry. Pharma Innovation J 2017;6:235-40.
8. Misar SN, Bhurghate AV, Sisodia JS, Gaikwad SK, Patil HB. Technology transfer: a paradigm for industry. Int J Pure Appl Biosci 2014;2:221-8.
9. Waghmare YS, Mahaparale SP. The important role of technology transfer in pharmaceutical industry-a review. World J Pharm Res 2017;6:310-29.
10. Mansfield, Edwin. International technology transfer: forms, resource requirements, and policies. Am Econ Rev 1975;65:372–6.
11. Souder WE, Nashar AS, Padmanathan V. A guide to the best technology transfer practices. J Technol Transf 1990;15:1-2.
12. Steenhuis HJ, de Boer SJ. Differentiating between types of technology transfer: the technology building. Int J Technol Transfer Commercialisation 2002;1:187-200.
13. Mohite PB, Sangle SV. Technology transfer in pharmaceutical industry-a review. Int J Adv Pharm Res 2017;6:1-7.
14. Good Practice Guide: Technology Transfer (Third Edition). Available from: https://guidance-docs.ispe.org/cdn-1590534466328/Good-Practice-Guide-Technology-Transfer-Third-Edition/. [Last accessed on 01 Dec 2020]
15. Manu C, Gupta V. Review on technology transfer in pharmaceutical industry. Int J Pharm Qual 2016;7:7-14.
16. Amanjeet, Aggarwal G. Technology transfer in pharmaceutical industry: a discussion. Int J Pharma Bio Sci 2010;1:1-5.
17. Pagar S, Khivansara A, Pagar P, Gandhi M, Jondhale S. Review article on technology transfer. Int J Pure Appl 2014;2:145-53.
18. Sajid A, Vinay P, Chander S. Technology transfer in pharmaceuticals. Int Res J Pharm 2012;3:43-8.
19. Manral M, Prashar B, Sheikh Y. Technology transfer in pharmaceutical industry: facts and steps involved. Am J Pharma Tech Res 2012;2:73-82.
20. Wani R, Kashid A, Ghatge A, Shaoo S. An overview of technology transfer in industry. Int J Adv Pharm 2017;6:103-9.
21. Ojha A, Mini. Technology transfer: a technique for providing novelistic platform to develop quality and efficiency in pharma sector. Eur J Biomed Pharm Sci 2014;1:49-77.
22. Patil R. Constituents and factors of technology transfer in pharmaceutical industry–learn about gmp: accredited online life science training courses [Internet]. Learn about gmp: Accredited online life science training courses; 2011. Available from: https://learnaboutgmp.com/good-manufacturing-practices-cgmp/constituents-and-factors-of-technology-transfer-in-pharmaceutical-industry/. [Last accessed on 03 Oct 2020]
23. Alam MS, Ahmad J. Pharmaceutical technology transfer: an overview. Int J Pharm Sci 2013;4:1.
24. Janodia M, Sreedhar D, Ligade VS, Udupa N. Facets of technology transfer: a perspective of pharmaceutical industry. J Intellect Prop Rights 2008;13:28-34.
25. Good manufacturing practices for sterile pharmaceutical products In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty sixth report. Geneva, World Health Organization; 1992.
26. Quality assurance of pharmaceuticals; 2006. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf. [Last accessed on 03 Oct 2020]
27. Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing; 2011. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/TransferTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf. [Last accessed on 03 Oct 2020]
28. ICH Harmonized Tripartite Guideline. Pharmaceutical development. Q8 (2R). As revised in August 2009. Geneva, ICH Secretariat; 2009. Available from: http://www.ich.org/lOB/media/MEDIA4986.pdf. [Last accessed on 03 Oct 2020]
29. Suthar R, Shah JS. Review on technology transfer as a regulatory aspect with inclusion of ICH guidelines. Asian J Pharm Technol Innov 2017;5:32-40.
30. Fong N. Principles of technology transfer; 2016. Available from: https://www.outsourcedpharma.com/doc/principles-of-technology-transfer-0001. [Last accessed on 03 Oct 2020]
31. FDA Technology Transfer Program. U. S. Food and Drug Administration; 2017. Available from: https://www.fda.gov/ science-research/fda-technology-transfer-program. [Last accessed on 01 Dec 2020]
32. Guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements. European Union; 2014.
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How to Cite
PAVITHRA, G. M., MANORANJITH, & NAGALAKSHMI, S. (2021). AN OVERVIEW OF TECHNOLOGY TRANSFER AS A REGULATORY ASPECT. International Journal of Applied Pharmaceutics, 13(2), 14-19. https://doi.org/10.22159/ijap.2021v13i2.40067
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Review Article(s)