The Center for Veterinary Biologics (CVB) recently added Draft Document 12135 – Veterinary Services Memorandum (VSM): 800.211 Guidance for Master Reference Qualification, Requalification, Dating, and Monitoring to its website for a 4-week comment period. The draft document and instructions for submitting comments are available on the Draft Guidance Documents for Comment webpage.
The purpose of this document is to preserve the guidance in the 2011 version of VSM 800.211 and seek to clarify and provide additional detail regarding dating of newly licensed product Master References and monitoring the stability of those references. This updated memorandum also includes guidance on reference qualification and requalification.
CVB will consider all comments received by September 20, 2021, before finalizing the guidance document.