Direct Links to important GMP Blood Product Guidelines
FDA Guidance for Industry
For the Submission of
Chemistry, Manufacturing and Controls and
Establishment Description Information for
Human Blood and Blood Components
Intended for Transfusion or for
Further Manufacture
and
For the Completion of the
This guidance is a list of what a new applicant should submit in support of an application to become a U.S. licensed manufacturer of human blood and blood components.
FDA Guidance for Industry
Content and Format of Chemistry,
Manufacturing and Controls Information
and Establishment Description
Information for a Biological In Vitro
Diagnostic Product
This document is intended for use by those firms which manufacture any licensed in vitro diagnostics used to screen donor blood, determine donor suitability, test for retroviral infection, or determine transfusion compatibility.
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products
3/2009
Recommendetions for the use of serological Test to reduce the risk of transmission of T. crzi with blood or tissue products
FDA Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes
This document provides recommendations to manufacturers of HBsAg assays that are intended to be used to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay.
FDA Guidance for FDA
Reviewers
Premarket Notification
Submissions for Transfer Sets
(Excluding Sterile Connecting
Devices)
This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for transfer sets (excluding sterile connecting devices) used in blood establishments.
FDA Guidance for Industry
Revised Recommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors
ecommendations Regarding
Invalidation of Test Results of Licensed
and 510(k) Cleared Bloodborne
Pathogen Assays Used to Test Donors
FDA Compliance Program Guidance Manual
Chapter 42 - Blood and Blood Products
Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
FDA Compliance Program Guidance Manual
Chapter 42 – Blood and Blood Products
Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002