GMP NEWS 2017

On 22 November, the European Commission adopted the expected new "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products" as the new stand alone document for the current requirements for authorised ATMP as well as for clinical trials.

Fundamental violations of GMP basics in the area of API production found in an official inspection usually lead to unpleasant consequences or, in case of FDA inspections, to a Warning Letter. Read more on which issues concerning in-process controls, documentation and OOS results are intolerable.

When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?

Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities. 

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.

Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.

The European Medicines Agency (EMA) evaluated an additional use for guidance relating to non-clinical evaluation of radiopharmaceuticals and published a new concept paper on the development of such a guidance.

Since 1 November, the MRA has been in the operational phase. The FDA now recognizes EU inspectorates in 8 of 28 countries - the majority of countries is not yet recognized.