The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 with regard to IMP labelling?
The annual report 2016 of the GCP Inspectors Working Group (IWG) has been published. According to the report EU inspectors have found more than 1000 clinical trial deficiencies in 2016. Read more about the Annual report of the Good Clinical Practice Inspectors Working Group 2016.
Additional changes to the USP general chapter <1090> have recently been proposed by the USP General Chapters—Dosage Forms Expert Committee. Read more about the revision of USP chapter Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution.
Besides IR and Raman, NIR is frequently used in the inspection of incoming active ingredients and excipients. New suggestions for updating the two NIR chapters were issued in the USP's Pharmacopeial Forum. Please find more information on the changes to the USP chapters <856> and <1119> on near-infrared spectroscopy.
Over the past months, the ECA reported about the growing number of Warning Letters issued to Asian companies. A recent FDA Warning Letter resulted in a ban on imports for a Chinese manufacturer of pharmaceutical products.
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 GMP directive is dead - long live the GMP directive. It was with this phrase that new kings were announced in France in order to demonstrate the monarchy's continuity. But what about content consistency between the old and the new directive? What are the differences between both GMP directives? What will change in the new GMP directive, what will stay the same?
The revised Ph. Eur. Monograph 3.2.9. on rubber closures will become official on July 1, 2018 (Supplement 9.5). Read more about Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.
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.
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?