Direct Links to important GMP Blood Product Guidelines

Guideline for inclusion in the Guideline on the Scientific data requirements for a Plasma Master File (EMEA/CPMP/BWP/3794/03).The requirement to collect epidemiological data on blood transmissible infections is intended to obtain information on the infection risk in a specific donor population and is thus an essential part of the measures taken to ensure an adequate selection of donors of blood and plasma. The purpose of these data is to characterise the donor population with respect to infection risk, and to allow comparison of risks between donor populations of individual collection centres.

This document gives recommendations on the design and conduct of studies to assess the relationship between doses, blood levels and clinical response throughout the clinical development of a new drug.

recommendations for a requalification method under 21 CFR 610.41(b) for deferred donors, based on a determination that their previous reactive test results for antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II) were falsely positive.