Direct Links to important GMP Blood Product Guidelines

FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

ecommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors

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FDA Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001

Compliance Program CBER Biologics

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

Compliance Program CBER Biologics

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

Compliance Program CBER Biologics

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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.

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

Cord Blood Processing System and Storage Container

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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

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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.

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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)

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FDA Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens

Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens

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GMP Conferences by Topics

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