Supply Chain Transparency in the New Virtual World

Historically, the relationship between Brand Owner and the Contract Manufacturer (CMO) involved an on-site audit of the manufacturing site. While the practical realities of Covid-19 have put a damper on that, the obligations under 21CFR Part 111 of both the Brand Owner and CMO never changed. While the FDA may have suspended on-site audits, they were still reviewing websites, literature, and issuing warning letters for non-conformities. This whitepaper from Gemini Pharmaceuticals will outline the approach the Brand Owner can take to ensure compliance with the regulations in these troubled times.