Direct Links to important GMP Blood Product Guidelines

Compliance Program Guidance Manual Chapter – 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices 7342.008

Compliance Program CBER Biologics

FDA FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation

The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs.

FDA Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

Cord Blood Processing System and Storage Container

FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container

Classification of Cord Blood Processing System and Storage Container

Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

This guidance document provides recommendations for the submission of a biologics license application (BLA) (21 CFR Part 601) for placental/umbilical cord blood products that are: manipulated minimally; and intended for hematopoietic reconstitution in patients with hematological malignancies; and intended to be used in recipients unrelated to the donor.

FDA Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Eudralex Volume 3 ANNEXES TO GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1

ANNEX A: List of Plasma-Derived Products 2 ANNEX I: Check list on the annual update 3 ANNEX II: Information on centres or establishments in which blood/plasma collection is carried out 9 ANNEX III: Information on centres or establishments in which testing of donations and plasma pools is carried out 12 ANNEX IV: Information on establishments or centres in which storage of plasma is carried out 15 ANNEX V: Information on organisations involved in transport of plasma 16

Eudralex Volume 3 PLASMA-DERIVED MEDICINAL PRODUCTS: POSITION PAPER ON ALT TESTING

Contents the current position to ALT Testing of blood derived products and why there is no scintific base of objecting plasma for use fractionation collected without ALT testing.

Eudralex Volume 3 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/ BIOLOGICAL PRODUCTS

The guidance stated in this annex applies to well-characterised proteins and polypeptides,their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. Thus, the document covers the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors),erythropoietins, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulins, monoclonal antibodies, and vaccines consisting of well-characterised proteins or polypeptides.

Eudralex Volume 3 NOTE FOR GUIDANCE ON GUIDANCE ON MINIMISING THE RISK OF TRANSMITTING ANIMAL SPONGIFORM ENCEPHALOPATHY AGENTS VIA HUMAN AND VETERINARY MEDICINAL PRODUCTS AMENDMENTS TO SECTIONS 6.2 AND 6.3

Changes and Additions about the minimising of risk of animal spongiform encephalopathy transmitted by gelatine and blood products

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