Technology Transfer a Global Perspective: Crux of the Matter
Volume 2, Issue 3, June 2014, Pages: 27-37
Received: Apr. 29, 2014;
Accepted: May 26, 2014;
Published: Jun. 10, 2014
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Ramesh S. Yamgar, ICLES’s, Motilal Zhunzhunwala College of Arts, Commerce and Science, Vashi, Navi Mumbai 400 703, INDIA
Sudhir S. Sawant, P. G. Dept. of Chemistry, Govt. of Maharashtra, Ismail Yusuf Arts, Science and Commerce College, Jogeshwari, Mumbai 400 060 INDIA
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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.
API Technology Transfer, Information Security, Process Trouble Shooting, Process Validation & DMF Filing, PAT, CAPA
To cite this article
Ramesh S. Yamgar,
Sudhir S. Sawant,
Technology Transfer a Global Perspective: Crux of the Matter, Science Research.
Vol. 2, No. 3,
2014, pp. 27-37.
Chronicle Pharmabiz, 4th July 2013
K.B. Saji, Karuna Jain, Int. J. of Technology Transfer and Commercialisation, 2006 Vol.5, No.3, 251 – 262.
Binay Kumar Pattnaik, Technology Transfer and In-House R&d in Indian Industry, Volume - 1999
J. C. Copplestone, Dr. C. M. Kirk , S. L. Death, N. G. Betteridge, S. M. Fellows , Heather Wansbrough, http://nzic.org.nz/ChemProcesses/production/1A.pdf.
ICH Topic Q3C (R4), Impurities: Guideline for Residual Sol-vents
(a) Muhlbauer, R.C., et al., J. Bone Miner. Res., 6, 1003 (1991). (b) Pecherstorfer, M., et al., J. Clin. Oncol., 14, 268 (1996).