Historically, the relationship between Brand Owner and the Contract Development and Manufacturing Organization (CDMO) 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 CDMO never changed. The Brand Owner needs to be prepared for when the FDA resumes on-site audits. This whitepaper from Gemini Pharmaceuticals will outline the approach the Brand Owner can take to ensure compliance with the regulations in these unusual times.
