In our top 10 of 2019, Dirk Rogers highlights news on the particles front (article here), as FDA expects a visual inspection program and parenteral manufacturers should expect questions during inspections.
Visual inspection of parenteral drug packaging remains a priority for manufacturers and the FDA, as explained by John Shabushnig, PhD of Insight Pharma Consulting and Richard Watson of Merck at the 2019 Parenteral Drug Association (PDA)/FDA Join Regulatory Conference held in Washington D.C. in Sep. 2019. Shabushnig monitors FDA recall notices, filtering on those that are due to visible particulate in parenterals.
Counting recall notices can be a little misleading because one notice can be for a single lot, or it can be for multiple lots and even multiple products, but it still offers a way to easily measure the frequency of occurrence of a given type of defect. …
