Technology development and transfer
Synopsis
WHO sets standards for technology transfer (TT), which includes quality risk management, terminology, the technology transfer method, and the steps that are taken from research and development to manufacturing, such as cleaning, processing, and packaging. It also talks about paperwork, the level of detail in the TT process (which includes APIs, excipients, final products, and packaging materials), facilities and tools, certification, and verification methods. Part of the standards are also quality control and the sharing of analytical methods. These are the jobs of approved authorities and regulatory agencies. Case studies show different parts of commercialization, such as difficulties and useful things to think about. APCTT, NRDC, TIFAC, BCIL, and TBSE/SIDBI are some of the TT bodies in India that help with this process. Also, paperwork linked to TT includes agreements to keep information private,
Keywords: Quality Risk Management, Analytical Methods, Regulatory Agencies Commercialization, Confidentiality Agreements