What is the technology transfer and how is it done?
Answers were Sorted based on User's Feedback
Answer / 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.
Is This Answer Correct ? | 2 Yes | 0 No |
Answer / md. sultan mahmud
It depends on the nature of transport sample.In case of bacteria use Stuart transport media and in case of virus uses VTM
Is This Answer Correct ? | 1 Yes | 1 No |
What do you mean by CAPA?
Which will give more drug release paddle or basket in dissolution?
2 Answers Aishwarya Healthcare,
Difference between Group-1 and Group-2 Exams
1.mechanism of action -metformin 2.schedule y related to wat 3.define half life 4.wat is teratogenicity
Why we said Glacial Acetic Acid to Acetic Acid m
What is difference between method validation and method verification?
In KF Standardization why we use Disodium Tartarate?
how quantitative stability studies are done?
how we can fix re-standardization due date in volumetric solution
what is the major definition and difference between uniformity of content and content uniformity as official test for all tablets?
how will convience the doctor
What is the disintegration time of coated tablets?