Direct Links to important GMP Blood Product Guidelines

FDA Guidance for Industry:Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products

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

more

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

more

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

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

more

Guidance for Industry:Notifying FDA of Fatalities Related to Blood Collection or Transfusion

Help for report fatalities related to blood and blood component (blood) collection or transfusion

more

Eudralex Volume 3 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

FDA Fatalities Reported to FDA Following Blood Collection and Transfusion 2014

Zusammenfassung aller Vorfälle bei Blutspende und Transfusion

more

ICH E4 DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION

This document gives recommendations on the design and conduct of studies to assess the relationship between doses, blood levels and clinical response throughout the clinical development of a new drug.

more

Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus

• Clinical experience with HEV infections and transfusion-associated infections: How serious are HEV infections and which patient populations may be particularly at risk? • HEV detection and epidemiology of HEV in blood/plasma donations • Do serum antibodies against HEV significantly neutralise? • Latest experience from studies on inactivation/removal of HEV: Which steps are effective to remove / inactivate HEV? Which model viruses can be used to assess that? Do we need more virus validation data?

more

FDA Guidance for Industry: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components

Recommendation to rduce Zika Risk transmission for Whole Blood donations. Does not apply for source plasma

more

Recommendations for Requalification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)

recommendations for a requalification method under 21 CFR 610.41(b) for deferred donors, based on a determination that their previous reactive test results for antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II) were falsely positive.

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