Direct Links to important GMP Blood Product Guidelines

FDA Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

This guidance document provides recommendations for complying with 21 CFR 610.47 and 21 CFR 610.48 to (1) blood establishments that collect blood or blood components, including Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees referring HCV

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.

FDA GUIDELINE FOR QUALITY ASSURANCE IN BLOOD ESTABLISHMENTS

The purpose of this guideline is to assist manufacturers of blood and blood components, including blood banks, transfusion services, and plasmapheresis centers, in developing a quality assurance (QA) program in their effort to be consistent with recognized principles of quality assurance and current good manufacturing practice (CGMP).

FDA DRAFT POINTS TO CONSIDER IN THE DESIGN AND IMPLEMENTATION OF FIELD TRIALS FOR BLOOD GROUPING REAGENTS AND ANTI-HUMAN GLOBULIN

intent in performing field trials on new Blood Grouping Reagents and Anti-Human Globulin Reagents and the subsequent impact on field trial design and implementation

FDA DRAFT RECOMMENDED METHODS FOR BLOOD GROUPING REAGENTS EVALUATION

These recommended methods are provided to help assist manufacturers in pursuing new product license applications and amendments to existing product license applications.

FDA Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)

Information about Blood collecting from High Risk donors with positive tests for Infecious diseases

FDA Guideline for the Uniform Labeling of Blood and Blood Components

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

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

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