Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and opens up various opportunities for the professionals in pharmaceutical domain. The coordination of various linked activities like procurement, quality , production, health & safety of the personnel involved in manufacturing and export have become more vital. This article discuss about various aspects of technology transfer like outsourcing key raw materials, information security to protect the intellectual property, various development strategies for API development and most significantly the practical difficulties encountered during API technology transfer. It is also describing certain trouble shooting issues, which were resolved with the help of reaction mechanism & chemistry involved in processes and investigations made to arrive at appropriate CAPA. This article is also indicating simple laboratory techniques/ instruments, which could be adopted to support PAT initiatives. It is also describing examples of how certain process improvements were achieved due to trouble shooting in scale up trial batches.
| Published in | Science Research (Volume 2, Issue 3) |
| DOI | 10.11648/j.sr.20140203.11 |
| Page(s) | 27-37 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2024. Published by Science Publishing Group |
API Technology Transfer, Information Security, Process Trouble Shooting, Process Validation & DMF Filing, PAT, CAPA
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| [5] | ICH Topic Q3C (R4), Impurities: Guideline for Residual Sol-vents |
| [6] | http://www.aioh.org.au/downloads/documents/ControlBandingBNaumann.pdf |
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APA Style
Ramesh S. Yamgar, Sudhir S. Sawant. (2014). Technology Transfer a Global Perspective: Crux of the Matter. Science Research, 2(3), 27-37. https://doi.org/10.11648/j.sr.20140203.11
ACS Style
Ramesh S. Yamgar; Sudhir S. Sawant. Technology Transfer a Global Perspective: Crux of the Matter. Sci. Res. 2014, 2(3), 27-37. doi: 10.11648/j.sr.20140203.11
AMA Style
Ramesh S. Yamgar, Sudhir S. Sawant. Technology Transfer a Global Perspective: Crux of the Matter. Sci Res. 2014;2(3):27-37. doi: 10.11648/j.sr.20140203.11
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Download@article{10.11648/j.sr.20140203.11,
author = {Ramesh S. Yamgar and Sudhir S. Sawant},
title = {Technology Transfer a Global Perspective: Crux of the Matter},
journal = {Science Research},
volume = {2},
number = {3},
pages = {27-37},
doi = {10.11648/j.sr.20140203.11},
url = {https://doi.org/10.11648/j.sr.20140203.11},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sr.20140203.11},
abstract = {Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and opens up various opportunities for the professionals in pharmaceutical domain. The coordination of various linked activities like procurement, quality , production, health & safety of the personnel involved in manufacturing and export have become more vital. This article discuss about various aspects of technology transfer like outsourcing key raw materials, information security to protect the intellectual property, various development strategies for API development and most significantly the practical difficulties encountered during API technology transfer. It is also describing certain trouble shooting issues, which were resolved with the help of reaction mechanism & chemistry involved in processes and investigations made to arrive at appropriate CAPA. This article is also indicating simple laboratory techniques/ instruments, which could be adopted to support PAT initiatives. It is also describing examples of how certain process improvements were achieved due to trouble shooting in scale up trial batches.},
year = {2014}
}
TY - JOUR T1 - Technology Transfer a Global Perspective: Crux of the Matter AU - Ramesh S. Yamgar AU - Sudhir S. Sawant Y1 - 2014/06/10 PY - 2014 N1 - https://doi.org/10.11648/j.sr.20140203.11 DO - 10.11648/j.sr.20140203.11 T2 - Science Research JF - Science Research JO - Science Research SP - 27 EP - 37 PB - Science Publishing Group SN - 2329-0927 UR - https://doi.org/10.11648/j.sr.20140203.11 AB - Technology transfer has become a key activity in the pharmaceutical manufacturing domain. The processes are developed in an R&D set up for the API or finished dosage forms and are transferred to another site in the same country or different geographic location. Due to changing business needs, technology transfer has become a global activity and opens up various opportunities for the professionals in pharmaceutical domain. The coordination of various linked activities like procurement, quality , production, health & safety of the personnel involved in manufacturing and export have become more vital. This article discuss about various aspects of technology transfer like outsourcing key raw materials, information security to protect the intellectual property, various development strategies for API development and most significantly the practical difficulties encountered during API technology transfer. It is also describing certain trouble shooting issues, which were resolved with the help of reaction mechanism & chemistry involved in processes and investigations made to arrive at appropriate CAPA. This article is also indicating simple laboratory techniques/ instruments, which could be adopted to support PAT initiatives. It is also describing examples of how certain process improvements were achieved due to trouble shooting in scale up trial batches. VL - 2 IS - 3 ER -
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