GMP News - Blood / Biologics and ATMP

27.08.13

FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

Computer validation will be an important topic for blood establishments too. The US FDA published a guideline on that topic in March 2013. Read more here.

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27.08.13

FDA Scientists link transfused UVB irradiated platelets with acute lung injury

Scientists at the U.S. Food and Drug Administration (FDA) have reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can mediate lung injury. Read more.

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11.07.13

Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

Related to changes to an approved application of human blood and blood components intended for transfusion or further manufacture, the FDA published a draft guidance for comment. Read more here.

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11.07.13

FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.

The US FDA has conducted retrospective analyses of data from a large health claims-related database as well as continued postmarketing adverse event reports of thrombosis. These analyses have strengthened the evidence for an association between the use of intravenous, subcutaneous, and intramuscular human immune globulin products and the risk of thrombosis. For that reason the authority now demands a boxed warning for the entire class of products. Read more.

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21.03.13

Safety of Blood Components for Transfusion and of Stem Cell Products: Testing for HIV, HBV and HCV

In February, the Paul-Ehrlich-Institut published a  notification on "Imposition of conditions pursuant to Section 28 (3) c AMG (Arzneimittelgesetz, German Medicines Act) for the purpose of risk prevention to assure the safety of blood components for transfusion and of stem cell products for haematopoetic reconstitution: Testing for HIV, HBV and HCV". Read more.

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21.03.13

FDA Recommendations for Syphilis Screening of Blood and Blood Components

In March 2013, the FDA published a draft guidance "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis". For more details read here.

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21.03.13

Technical Update of Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors

The FDA updated the ongoing Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 of the Compliance Program Guidance Manual. Get more details.

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18.02.13

Starting Materials and Intermediates

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. This includes information related to starting and raw materials. The draft reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products i supposed to provide information on that topic. Read more here.

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18.02.13

Risk-based Approach to Advanced Therapy Medicinal Products

In 2012, the EMA Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products was open for comments. The risk-based approach is based on the identification of various risks associated with the clinical use of an ATMP and risk factors inherent to the ATMP with respect to quality, safety and efficacy. To learn more about this, click here.

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18.02.13

Warning on transmissible Agents

When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. The "Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products" updates the previous recommendations and states the warning to be included in the SmPC and Package Leaflet of any plasma-derived medicinal product. More details can be found here.

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18.02.13

Isolation of Candidate Influenza Vaccine Viruses in Cell Culture

In Febraury 2012 EMA's "Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture" became official. The scope of this document is to provide guidance for the isolation on cell culture of any potential influenza vaccine virus intended for cell culture or egg-based influenza vaccine manufacture. More details can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor IX Products

In February 2012 the "Guideline on clinical investigation of recombinant and human plasma-derived factor IX products" came into effect. The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor IX products. More can be found here.

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18.02.13

Recombinant and Human Plasma-derived Factor VIII Products

The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation for recombinant or plasma-derived factor VIII products. Find out more.

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18.02.13

Plasma-derived Medicinal Products

Providing guidance for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products the "Guideline on plasma-derived medicinal products" became effective in 2012. Read on here.

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