February 14th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Nitto Avecia Pharma Services
Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry, Manufacturing, and Controls and Toxicology.
FDA’s Dan Mellon, a toxicology supervisor with the Center for Drug Evaluation and Research, addressed these issues during an interview with the Parenteral Drug Association.
On the industry side, a coordinated effort is also necessary to conduct successful extractables and leachables studies, according to Nitto Avecia Pharma Services.
The contract development and manufacturing organization addressed this need for coordination in a 2018 webinar hosted by Xtalks.2
Answers to audience inquiries were provided by Aryo A. Nikopour, Nitto Aveci Pharma Services’ Senior Vice President of Scientific and Technical Services. For more information, please click here for the webinar recording: A Systematic Approach to Extractables and Leachables.
Posted in: Pharmaceutical Online