Direct Links to important GMP Blood Product Guidelines

DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices

This Directive aims at including in the scope of Directive 93/42/EEC (2) only medical devices which incorporate,as an integral part, substances derived from human blood or human plasma.

DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma

In addition to being directed at medical devices for in vitro diagnosis, the Commission proposal sought to amend Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (4) in order to extend its scope to medical devices manufactured by using nonviable tissues or substances of human origin derived from those tissues. This amendment was not included in Directive 98/79/EC (5) when it was adopted.

EU GMP Annex 14: Manufacture of Products derived from Human Blood or Human Plasma (May 2011) - Deadline for coming into operation: 30 November 2011

Manufacture of medicinal products derived from human blood or plasmablood

WHO Good Manufacuring Practices for blood establishments

WHO requirements on the collection, processing an quality control of blood, blood components and plasma derivates

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

This Compliance Program covers Source Plasma, Source Leukocytes, and Therapeutic Exchange Plasma intended for further manufacture into injectable drug products (e.g. immune globulin, albumin) and noninjectable products (e.g. in-vitro devices such as blood bank reagents), which are biological products subject to the licensure provisions of Section 351 of the Public Health Service Act (PHS).

FDA Guidance for Industy: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus

recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA).

FDA Guidance for Industry Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (21 CFR 630.15(b)(8)). This guidance supersedes the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance).

FDA Guidance for Industry:Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

This guidance is intended to amend the guidance entitled "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

FDA Guidance for Industry Blood Establishment Computer System 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

Eudralex Volume 3 Good Practice Guidelines for Blood Establishments to Comply with EU Directive 2005/62/EC

The document identifies the quality system elements that must be met by blood establishments that are required to comply with EU Directive 2005/62/EC.

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