GMP News - Quality Assurance

How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.

With the publication EMA's guideline on Shared and Dedicated Facilities and the revision of Annex 15, the topic of cleaning validation has gained new attention. The PDE concept is now the determining factor. But what about the FDA?

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

The MRA with the USA was supplemented by two further countries: Poland and Slovenia. However some are still missing.

In January 2019, the World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) published a draft guideline dealing specifically with the GMP requirements for the manufacture of radiopharmaceuticals.