BIO375H5 Study Guide - Midterm Guide: Good Manufacturing Practice, Diethylene Glycol, Antifreeze
Document Summary
In 1937, many children died after receiving treatment for sore throat: If you want to sell your drug, the drug needs to be approved by health authority: classify as, class 1: lowest risk, class 2: risk is median, class 3: risk is highest. Fda: pre-market: check for phase 1,2,3 testing. The: post market: drugs already been on the market, want to see if there has been major point is to make sure the drug is effective/make sure it works. Second it is for safety (make sure its safe). Third, to make sure that the manufacturing process and the facility are up to standards. any side effects. Make sure all equipment is up to standards and good manufacturing practice (gmp). What does fda regulate: drugs, blood, medicinal devices, diagnostic tests, fda does not regulate water from the tap but it does regulate water that is bottled. Fda is only respobsible for the pre-market section but not the post-market section.
