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What is the technology transfer and how is it done?
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Answer Posted / manish sharma
Technology transfer is a process to transfer information and technologies necessary to manufacture quality drug product consistently or technology transfer is the process of taking an invention from its inception in a laboratory to a commercialized product.
Analytical department analyst along with quality control analyst has to perform analysis as per the analytical method transfer protocol.
* The transfer activity shall be established on the optimization batch or process batch with the final formula.
* Analytical method transfer activity shall be initiated with analytical method transfer protocol prepared by AR&D, reviewed by DQA/QC and finally approved by QA.
* The analytical method transfer protocol shall explain the transfer activities of the drug product and also the parameters that shall be transferred are Assay, Dissolution, Related substances, Content uniformity and Residual solvents.
* In case of multiple strengths, analytical method transfer shall be performed for lower strength.
* All chromatograms, record of results and other information have to be interlinked and records have to be maintained.
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