GMP NEWS 2021

The European Commission is planning to create a new EU Health Emergency Preparedness and Response Authority (HERA). For this purpose, the Commission has opened a feedback procedure.

We keep receiving questions about the extent to which remote QP certifications are possible in the current situation. Unfortunately, the legislation in the individual EU Member States is not uniform.

Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products. 

Due to the current pandemic and the associated restrictions, assessments are increasingly being performed remotely. Are these Distant Assessments also an option for the post-pandemic period?

With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.

Brexit: The agreement on the future relationship between the European Union and the United Kingdom is here. What are the consequences for medicinal products?

A new policy for dissolution and disintegration testing in European Pharmacopoeia (Ph. Eur.) monographs has been adopted at the 168th session of the European Pharmacopoeia Commission (November 2020). A dissolution or disintegration test will be included in each medicinal product monograph on an immediate-release solid dosage form.