GMP Inspectors Zero In On Contaminants, “Goodness” Of Basic Tests
This article was originally published in The Tan Sheet
Executive Summary
Good manufacturing practice inspectors are looking for contamination from chloramphenicol, solvents, micro-bacterial treatments and elements such as lead and arsenic, FDA’s Fabricant says. He also says inspectors are testing the validity of specification and identity tests firms use to meet basic GMP requirements.