BLG 699 Lecture Notes - Lecture 10: World Gastroenterology Organisation, Mylan, Purified Water
Document Summary
Set of policies and procedures for manufacturers of drug products: the facilities, equipment, methods, and controls for producing drugs with the intended quality. Quality cannot be tested into a product: must be designed and, built into each batch of the drug product throughout all aspects of its manufacturing processes. Manufacturers are required to abide by the gmp regulatory guidelines to ensure drugs are pure, consistent, safe, and effective. Differences in emphasis and implementation in specific areas. Since april, hc has issued recalls for 3 generic oral contraceptives made in india. More than 620,000 packages have been pulled from shelves in that time. Recalled because they contained too many placebos in place of active doses of medication - caused bleeding and unplanned pregnancy. Mylan blamed a packaging issue and said it is investigating. A total of 428 domestic and 13 foreign on-site drug gmp inspection were conducted. Compliance rate was 96% wth 19 nc ratings issued.
