Who Needs GMP Training — and When?

摘要

Biopharmaceutical startups, especially virtual companies, are staffed by handfuls of people who wear enough hats to do the Kentucky Derby proud. A head of research may be reviewing master batch records (MBRs), approving analytical method validation protocols, and writing chemistry, manufacturing, and controls (CMC) amendments to an investigational new drug (IND) application. On the other hand, a chief executive officer (CEO) might have little, if any, regulated industry experience. Often a CEO foundsa virtual company after discovering a "Miracle Molecule" or might be brought on because of success in another industry.