Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
After many postponements, the long awaited Annex 1 draft of the EU GMP Guideline has finally been published on 20 December, 2017. While the chapters on integrity testing and visual inspection of injectables used to be rather short, the draft now contains several updates.
The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation.
A Canadian manufacturer of medicinal products received an FDA Warning Letter due to the fact that not all batches of manufactured drug products and the active materials used therein had been tested for compliance with the specifications before their release. Get information on the Cellex-C FDA Warning Letter.
It's a well-known fact that the US FDA publishes GMP deficiencies in their Warning Letters. For some years now, there has also been a European portal, where non-compliance results are published. In August 2017, an Upper Bavarian supervisory agency has issued such a statement of non-compliance with GMP to an Indian manufacturer of medicinal products. Which deficiencies were found?
The new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.
The European Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP Guideline.
The Detailed Commission Guidelines on GMP for IMPs have now been published as final in Annex 13 in EudraLex Volume 4.
With the resignation of Richard M Bonner as Chairman of the Advisory Board of both the ECA Foundation and the European QP Association (EQPA) the organsation has announced changes in the Advisory Boards of the ECA Foundation and the EQPA.
The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.