GMP News - Blood / Biologics and ATMP

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.

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

The FDA has already updated its recommendations on handling plasma donations from COVID-19 diseased donors several times. Recently, a new update of the Guidance for Industry Investigational COVID-19 Convalescent Plasma was published.

In December, the FDA updated its important information for blood establishments and transfusion services on bacterial contamination of platelets for transfusion, which has been published since 2016.

The final EMA Guidelines on the quality requirements for IMPs (pharmaceutical and biopharmaceutical drugs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. Many of the comments related to the question "What is a Non-substantial Modification?".

With the final publication of a guidance document on the implementation of a pathogen reduction system for blood components, the FDA complements its guidance documents on blood, blood products and plasma.

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?