GMP News - Blood / Biologics and ATMP

In addition to the existing guidance on donor eligibility, the FDA published a new guidance document on " Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use"

The European Medicines Agency published a new draft on the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

End of July, the Europeam Medicines Agency published a draft "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs". It is a part of the strategy to reduce animal testing in laboratories.

As a part  of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products".

End of June, the European Commission issued a stakeholder consultation on the draft guideline Good Manufacturing Practice for Advanced Therapy Medicinal Products.

In addition to their Guidance on donor screening and deferral concerning the risk of ZIKA virus transmission, the FDA now published a Q&A documenmt to answer the common questions of blood establishments. Read more about the "Questions and Answers Regarding “Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry”.

Biosimilarity of Monoclonal Antibodies - the WHO published a revised draft of their Guidelines on evaluation of monoclonal antibodies as 5 similar biotherapeutic products (SBPs).