PHARMACEUTICAL TECHNOLOGY TRANSFER: AN OVERVIEWAbstract
The article attempts to discuss the issues associated with technology transfer in the pharmaceutical industry. A major decision focuses on that point where the idea or process is advanced from a research- oriented program to target toward commercialization. The success of any program is highly dependent on the effectiveness of the communication preceding its implementation. The ultimate goal for successful technology transfer is to have documented evidence that the manufacturing processes for drug substances and drug product, respectively, are robust and effective in producing the drug substances and drug product complying with the registered specifications and Good Manufacturing Practice requirements. The Pharmaceutical Technology Transfer activities are to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement. To take all the gathered knowledge and use it as the basis for the manufacturing control strategy, the approach to process qualification and on-going continuous improvement.
Md. Shoaib Alam* and Javed Ahmad
PDL – Formulation; Ranbaxy Laboratories Limited 1, Paonta Sahib-173025, Himachal Pradesh, India
01 March, 2013
21 April, 2013
17 June, 2013
01 July, 2013