AN OVERVIEW OF TECHNOLOGY TRANSFER AS A REGULATORY ASPECT

Technology Transfer

  • Dr.S. Nagalakshmi Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai-600116, India
  • G.M.pavithra Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai-600116, India

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 intension 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 transfer.

Keywords: Technology transfer, Pharmaceutical industry, Barriers, Steps involved, Research & Development, Pharmaceutical production, Regulatory aspects

References

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3. Talokar SS, Vakhariya RR. Technology Transfer:-A Buzz Word in Pharmaworld. Asian Journal of Research in Pharmaceutical Science. 2017;7(1):18-22.
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6. Rani SS, Rao BM, Ramaro P, Kumar S. Technology Transfer-Models and Mechanism. International Journal of Mechanical Engineering and Technology. 2018;9(6):971-82.
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10. Dogra R, Garg R, Jatav P. Technology Transfer in Pharmaceutical Industry: Transfer of Process from development to Commercialization. International Journal of Pharmaceutical Sciences and Research. 2013;4(5):1692-1708.
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16. Pagar S, Khivansara A, Pagar P, Gandhi M and Jondhale S. Review Article on Technology Transfer. International Journal of Pure & Applied Bioscience. 2014;2(3):145-153.
17. Sajid A, Vinay P, Chander S. Technology Transfer in Pharmaceuticals. International Research Journal of Pharmacy. 2012;3(6):43-48.
18. Manral M, Prashar B, Sheikh Y. Technology Transfer in Pharmaceutical Industry: Facts and Steps Involved. Am. J. Pharma Tech Res. 2012;2(4):73-82.
19. Wani R, Kashid A, Ghatge A, Shaoo S. An overview of technology transfer in industry. International Journal of Advances in Pharmaceutics. 2017;6(6):103-109.
20. Ojha A, Mini. TECHNOLOGY TRANSFER: A TECHNIQUE FOR PROVIDING NOVELISTIC PLATFORM TO DEVELOP QUALITY AND EFFICIENCY IN PHARMA SECTOR. European Journal of Biomedical and Pharmaceutical Sciences. 2014;1(2).
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23. Janodia M, Sreedhar D, Ligade VS, Udupa N. Facets of Technology Transfer: A perspective of pharmaceutical industry. Journal of Intellectual Property Rights. 2008;13:28-34.
24. Good manufacturing practices for sterile pharmaceutical products In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty sixth report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 957, 2010), Annex 4; WHO Technical Report Series, No. 961, 2011) Annex 6.
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27. ICH Harmonized Tripartite Guideline. Pharmaceutical development. Q8 (2R). As revised in August 2009. Geneva, ICH Secretariat, 2009 (http://www.ich. org/LOB/media/MEDIA4986.pdf last accessed 27 July 2010).
28. Suthar R, Shah JS. Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines. Asian Journal of Pharmaceutical Technology & Innovation. 2017;05(23):32-40.
29. Fong N. Principles of Technology Transfer [Internet]. 2016 [cited 3 October 2020]. Available from: https://www.outsourcedpharma.com/doc/principles-of-technology-transfer-0001






1. Ramanathan. K. An Overview of Technology Transfer and Technology Transfer Models [Internet]. Tto.boun.edu.tr. [cited 3 October 2020]. Available from: http://tto.boun.edu.tr/files/1383812118_An%20overview%20of%20TT%20and%20TT%20Models.pdf
2. Allamneni Y, Chary PD, Kumar SC, Rao VB. Technology Transfer Process in Pharmaceutical Industry: An Overview | PharmaTutor [Internet]. Pharmatutor.org. 2020 [cited 2020 Mar 31]. Available from: https://www.pharmatutor.org/articles/overview-of-technology-transfer-in-pharmaceutical-industry
3. Talokar SS, Vakhariya RR. Technology Transfer:-A Buzz Word in Pharmaworld. Asian Journal of Research in Pharmaceutical Science. 2017;7(1):18-22.
4. Amneet K, Sharma OP, Jatinder D. Technology Transfer in Pharmaceutical Industry. International Journal of Current Pharmaceutical Research. 2013;5(1):16-18.
5. Bhusan B, Nautiyal U, Kumar S, Bakar A. Technology Transfer in Pharmaceutical Industry: A review. International Journal of Pharmaceutical and Medicinal Research. 2014;2(3):94-99
6. Rani SS, Rao BM, Ramaro P, Kumar S. Technology Transfer-Models and Mechanism. International Journal of Mechanical Engineering and Technology. 2018;9(6):971-82.
7. John RM. Technology transfer in pharmaceutical industry. The Pharma Innovation. 2017 ;6(3):235-240.
8. Misar SN, Bhurghate AV, Sisodia JS, Gaikwad SK, Patil HB. Technology Transfer: A Paradigm for Industry. International Journal of Pure& Applied Bioscience. 2014;2(2):221-228.
9. Waghmare YS, Mahaparale SP. The Important Role of Technology Transfer in Pharmaceutical Industry-A Review. World Journal of Pharmaceutical Research. 2017;6(9):310-329.
10. Dogra R, Garg R, Jatav P. Technology Transfer in Pharmaceutical Industry: Transfer of Process from development to Commercialization. International Journal of Pharmaceutical Sciences and Research. 2013;4(5):1692-1708.
11. Silva Luzia A. Development of Injectable Drugs: Technology Transfer and Process Validation [Master of Science in Pharmaceutical Engineering]. Technico lisboa; 2017.
12. Steenhuis HJ, de Boer SJ. Differentiating between types of technology transfer: the technology building. International journal of technology transfer and commercialisation. 2002;1(1/2):187-200.
13. Mohite PB, Sangle SV. Technology Transfer in pharmaceutical Industry- A Review. International Journal of Advances in Pharmaceutics. 2017;06(01):01-07.
14. Amanjeet, Aggarwal G. Technology Transfer in Pharmaceutical Industry: A Discussion. International Journal of Pharma and Bio Sciences. 2010;1(3):1-5.
15. Amanjeet, Aggarwal G. Technology Transfer in Pharmaceutical Industry: A Discussion. International Journal of Pharma and Bio Sciences. 2010;1(3):1-5.
16. Pagar S, Khivansara A, Pagar P, Gandhi M and Jondhale S. Review Article on Technology Transfer. International Journal of Pure & Applied Bioscience. 2014;2(3):145-153.
17. Sajid A, Vinay P, Chander S. Technology Transfer in Pharmaceuticals. International Research Journal of Pharmacy. 2012;3(6):43-48.
18. Manral M, Prashar B, Sheikh Y. Technology Transfer in Pharmaceutical Industry: Facts and Steps Involved. Am. J. Pharma Tech Res. 2012;2(4):73-82.
19. Wani R, Kashid A, Ghatge A, Shaoo S. An overview of technology transfer in industry. International Journal of Advances in Pharmaceutics. 2017;6(6):103-109.
20. Ojha A, Mini. TECHNOLOGY TRANSFER: A TECHNIQUE FOR PROVIDING NOVELISTIC PLATFORM TO DEVELOP QUALITY AND EFFICIENCY IN PHARMA SECTOR. European Journal of Biomedical and Pharmaceutical Sciences. 2014;1(2).
21. 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 [cited 3 October 2020]. Available from: https://learnaboutgmp.com/good-manufacturing-practices-cgmp/constituents-and-factors-of-technology-transfer-in-pharmaceutical-industry/
22. Alam MS, Ahmad J. Pharmaceutical Technology transfer: An Overview. International Journal of Pharmaceutical Sciences and Research. 2013;4(7):2441.
23. Janodia M, Sreedhar D, Ligade VS, Udupa N. Facets of Technology Transfer: A perspective of pharmaceutical industry. Journal of Intellectual Property Rights. 2008;13:28-34.
24. Good manufacturing practices for sterile pharmaceutical products In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty sixth report. Geneva, World Health Organization, 1992 (WHO Technical Report Series, No. 957, 2010), Annex 4; WHO Technical Report Series, No. 961, 2011) Annex 6.
25. Quality assurance of pharmaceuticals [Internet]. Who.int. 2006 [cited 3 October 2020]. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf
26. Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing [Internet]. Who.int. 2011 [cited 3 October 2020]. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/TransferTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf
27. ICH Harmonized Tripartite Guideline. Pharmaceutical development. Q8 (2R). As revised in August 2009. Geneva, ICH Secretariat, 2009 (http://www.ich. org/LOB/media/MEDIA4986.pdf last accessed 27 July 2010).
28. Suthar R, Shah JS. Review on Technology Transfer as a Regulatory Aspect with Inclusion of ICH Guidelines. Asian Journal of Pharmaceutical Technology & Innovation. 2017;05(23):32-40.
29. Fong N. Principles of Technology Transfer [Internet]. 2016 [cited 3 October 2020]. Available from: https://www.outsourcedpharma.com/doc/principles-of-technology-transfer-0001
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Dr.S. Nagalakshmi, & G.M.pavithra. (2021). AN OVERVIEW OF TECHNOLOGY TRANSFER AS A REGULATORY ASPECT: Technology Transfer. International Journal of Applied Pharmaceutics, 13(2). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/40067
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