07.27.23 -- 3 Action Items To Mitigate Supply Vulnerabilities

The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but biopharma companies and the FDA both have roles to fill in this need.

In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.