Dino Muzzin, Senior Vice President, Manufacturing Operations at Emergent, recently contributed to an article in BioPharm International titled, Good Manufacturing Practices: Challenges with Compliance.
In this article, Muzzin and other industry experts discuss obstacles, best practices for compliance, and where further guidance may be needed to fill the gaps in GMPs.
Excerpted from BioPharm International editorial titled, "Good Manufacturing Practices: Challenges with Compliance"
Best practices for compliance
BioPharm: Are there any ‘best practice’ advice or tips you can recommend for new organizations (e.g., at a start-up), specifically on how to practice and comply with GMPs?
Muzzin (Emergent): It is important to stay abreast of the latest guidance from FDA and other regulatory agencies. To ensure a robust understanding of your product and process, engage early, with specific questions and information, with the agency. If the technology being leveraged is new or novel, be ready to display a deep understanding of the technology and its appropriateness for use with your product or process to the agency.
Read the full article here.
Vol. 33, No. 6
L. Lavelle, "Good Manufacturing Practices: Challenges with Compliance," BioPharm International 33 (6) 2020.