Blog

Particles in Parenterals: 2019 Update

FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019? 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 theĀ 2019 Parenteral Drug…
Read more

Visual Inspection and Particulate Control

Visual Inspection and Particulate Control is co-authored by our CSO, Roy Cherris, is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize…
Read more

New Guidance for Visual Inspection

Article Written By: Roy Cherris, Bridge Associates International | May 30, 2017 As an industry, we have been performing 100% visual inspection for visible particles in parenterals for more than 70 years. Yet, during much of this time, there has been a lack of clear guidance, or harmonized scientific approach, for particulate and physical defects.…
Read more