CMCReviewandManufacturing(CGMP)inInvestigational.pptVIP

CMC Review and manufacturing (CGMP) Issues - Joneckis Presentation Overview Chemistry Manufacturing and Control (CMC) General Principles Approach Information to submit in an IND Good Manufacturing Practices (GMPs) General Principles Approach Specific Considerations Focus mostly on biologics and biotechnology products in early phase of clinical study Product class, specific product can influences CMC information to submit and approach to CGMP Consult – Guidance CBER group responsible for review of your product CMC/ CGMP Goals in Clinical Investigation Assure safe investigational products