GMP News - Blood / Biologics and ATMP

The FDA has revised the guidance regarding recommendations for blood establishments to defer donors for persons with an increased risk for human immunodeficiency virus (HIV) transmission.

As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.

During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.

At a time of increased interest in mRNA-based medicinal products and vaccines, the USP has published for comment a draft guidance document on "Analytical Methods for the Quality of mRNA Vaccines".

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.