FDA s GMP Expectations for Phase I and First-in-Man Clinical Tri

FDA s GMP Expectations for Phase I and First-in-Man Clinical Tri

Course Description Because a phase one clinical trial initially introduces an investigational new drug into human subjects appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase one investigational drugs (i.e. interpreting and implementing CGMP consistent with good scientific methodology) which foster CGMP activities that are more appropriate for phase one clinical trials improve the quality of phase one investigational drugs and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.The following steps to establish the appropriate manufacturing environment for phase one investigational drugs should be taken A comprehensive and systematic evaluation of the manufacturing setting (i.e. product environment equipment process personnel materials) to identify potential hazards...