GMP News - Blood / Biologics and ATMP

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

With the development of more and more guidance documents in the field of ATMP, new questions arise. The EMA has therefore published a Q&As paper on the GMP requirements for ATMPs.

The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.

In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.

An FDA document on Biological Product Deviation refers to products based on human tissues or cells.