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A comparison between CSV Guideline / regulations in Japan, India and China

Written by PQE Group | Aug 23, 2021 9:00:00 PM

Under the COVID-19 outbreak, since the world has been seeking its vaccines and remedies, several pharmaceutical companies have developed vaccines and their vaccinations have already started in some countries after approvals.
These newly developed vaccines reveal a structure in which the drug is consumed not only in the country of manufacture, but around the world. This means that the pharmaceutical industry is required not only to meet its own national regulations, but also ensure world-class quality, efficacy and safety for drugs.
Therefore, we research here the rules of Computerized System Validation (CSV) in Asia, in particular, China, India, and Japan which have an overwhelming population and a solid consumer market and are important manufacturing bases for pharmaceuticals, to confirm their measurements of guaranteeing the quality, effectiveness, and safety for drugs.