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.
The EMA recently revised its post-authorization procedural advice for users of the centralized procedure. Read more about new and revised Q&A´s concerning Periodic Safety Update Reports (PSURs).
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 European Medicines Agency (EMA) recently revised its post-authorization procedural advice for users of the centralized procedure.
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.
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.