GMP News - Blood / Biologics and ATMP

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.