Direct Links to important GMP Blood Product Guidelines

FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices: Reclassification of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle; Final Rule

The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.

more

CONCEPT PAPER ON the revision of the GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS EMEA/CPMP/BWP/125/04)requirements for a Plasma Master File

Guideline for inclusion in the Guideline on the Scientific data requirements for a Plasma Master File (EMEA/CPMP/BWP/3794/03).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.

more

Eudralex Volume 3 APPENDICESa TO GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS

APPENDICESa TO GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS

more

FDA Guidance for Industry and FDA Staff Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting th

Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications

more

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.

more

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.

more

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

more

WHO Good Manufacuring Practices for blood establishments

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

more

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).

more

FDA Guidance for Industry Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria

This guidance document provides blood establishments that collect blood and blood components, with FDA's, recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria.

more

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK