Direct Links to important GMP Blood Product Guidelines

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

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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.

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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.

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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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FDA Guidance for Industry “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV

This guidance document provides recommendations for complying with 21 CFR 610.47 and 21 CFR 610.48 to (1) blood establishments that collect blood or blood components, including Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees. This guidance does not apply to autologous donations, all Lookback donations (see p.4 for definition) that are identified as at increased risk of transmitting HCV, pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures, and blood and blood components that were intended for manufacture into non-injectable products subject to the labeling described in Section V.

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FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE

This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS). The BECS that is incorporated into a Blood Establishment Computer System may be manufactured either in-house or by a software manufacturer/vendor.

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FDA Guidance for Industry Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes

This document provides recommendations to manufacturers of HBsAg assays that are intended to be used to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay.

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FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

This guidance document identifies the relevant classification regulation, which provides a description of the applicable automated blood cell separator device (refer to section IV. – Device Description, below). In addition, other sections of this special controls guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with general controls, will ordinarily address the risks associated with these automated blood cell separator devices.

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FDA Guidance for Industry and FDA Review Staff Collection of Platelets by Automated Methods

This guidance provides you, blood establishments, and FDA staff with revised recommendations for the collection of Platelets by automated methods (plateletpheresis). This guidance is intended to help you ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device.

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FDA Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

We, FDA, are issuing this guidance document in conjunction with a Federal Register final rule reclassifying from class III to class II the automated blood cell separator device operating on a centrifugal separation principle intended for the routine collection of blood and blood components. This guidance document serves as the special control to support the reclassification. This guidance document also serves as the special control for the automated blood cell separator device operating on a filtration separation principle intended for the routine collection of blood and blood components reclassified as class II on February 28, 2003 (68 FR 9530). Special controls, when combined with general controls, ordinarily address the risks associated with use of the device.

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