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 - Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

Labeling of Blood and Blood products incl. Electronic Data Processing (EDP)

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 FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components

Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components

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

Compliance Program CBER Biologics

FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002