Direct Links to important GMP Blood Product Guidelines

21 CFR Part 606 Current Good Manufacturing Practice for Blood and Blood Components

US GMP Requirements for manufacturers of blood and blood components


PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007

This document applies to blood and apheresis establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of human blood and blood components.


FDA Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility

FDA, is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.


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

This document provides guidance for inspections of Source Plasma Establishments by FDA staff



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.


FDA Guidance for Industry Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Recommendations related to Donor deferral to minimise transmission risk of HIV via blood and blodd components


FDA Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

This guidance provides recommendations to blood establishment, for obtaining written informed consent from a prospective Source Plasma donor participating in a plasmapheresis program or an immunization program


FDA Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components

This guidance provides blood establishments that collect blood and blood components intended for transfusion or for further manufacture (referred to as "manufacturers" or "you") with advice on reporting to the Food and Drug Administration (FDA) a manufacturing change consisting of the implementation of a standardized full-length donor history questionnaire and accompanying materials (DHQ documents).


FDA Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments

Recommendations for Reporting of BPD (Biological Product Deviation)


FDA Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels

Requirements of standard uniformed labeling of Blood and Blodd componenets containers


GMP Conferences by Topics

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