Category Archives: Quality

Phase 1 Virtual Pharma cGMP

Together with Diane McGuire (PharmAcumen Consulting, Inc), I’ve authored an article to help Phase 1 US-only virtual manufacturers decide how much of a cGMP quality system they need – by examining laws, regulations and guidance. We’d love to get feedback on this topic. Have we missed anything? Gone too far? Leave a comment below, use the comment section at Outsourced Pharma, or drop me a line directly at pasmith@pharmintellectconsulting.com

https://www.outsourcedpharma.com/doc/does-a-phase-virtual-biopharma-company-need-a-cgmp-quality-system-0001