GMP News - Quality Assurance

The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM. The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.

The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.

The question in the title "Are consultants a universal remedy?" is of course a bit provocative. Yet the sole involvement of a consultant following a 483 deficiency report from the FDA is often insufficient. Why?

The European QP Association published a new version 9.0 its "Code of Practice for QPs". It now also comprises a new chapter "Ethics for the Qualified Person - A Professional Code of Conduct" in addition to general revisions and a revised Annex 1 with the national requirements.

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).

Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.