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.