GMP NEWS 2018

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 European Medicines Agency (EMA) recently revised its post-authorization procedural advice for users of the centralized procedure.

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.

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.

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?