GMP News - Blood / Biologics and ATMP

The European Medicines Agency (EMA) published a concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus and wants to organise a workshop to address the relevant issues. Read more.

After a request of the International Council for Commonality in Blood Banking Automation, the FDA published a Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. Get more details.

On 6 March, the CBER published a new guideline for Industry as well as for FDA staff related to the Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood.

A new era has begun with the publication of the draft on the revision of Annex 15 (Validation/ Qualification) with regard to validation. The volume has grown from 11 to 17 pages. A few new chapters have been added, whereas much familiar information is missing. You will find a detailed analysis in the News.

On 31 January 2014 the PIC/S Committee has adopted  the revision of the PIC/S GMP Guide (PE 009-11). The revised GMP Guide will enter into force on 1 March 2014. Find here more details.

The Active Substance Master File (ASMF) describes the quality of an API and is an essential document for the marketing authorisation of medicinal products. The procedure to submit an ASMF has been recently updated and described extensively in a new EMA Q&A document. Read more about the newest provisions.

Scientists at the US Food and Drug Administration (FDA) have demonstrated in animal studies a proof-of-concept approach that might reduce the bacterial burden of room temperature stored human platelets. For more details read here.