The Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.
ISPE will be collecting comments for the proposed amendments from interested members. Please submit comments to email@example.com by 25 August 2011.
Nominate Your Facility for 2018 Facility of the Year Awards
Thursday, 23 Mar 2017 18.03
New Format Highlights 2017 ISPE/FDA/PQRI Quality Manufacturing Conference
Wednesday, 22 Mar 2017 16.03
Looking Ahead – 2017 Pharmaceutical Industry Trends
Monday, 20 Mar 2017 18.03