Best Practices for Investigating Quality Deviations
The COVID-19 pandemic has led to a significant backlog of delayed inspections, and the FDA is now...
Browse Content
Preparing for FDA Remote Inspections
Stay ahead of the curve by learning from experts about virtual inspection training, preparing you for next...
LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements
Large Volume Parenterals (LVPs) can be packaged in a variety of formats made from polyolefins, including pouches,...
Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an...
Primary and Secondary Packaging Materials as Potential Source of Nitrosamines
Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation...
Risk Assessment for Potential Elemental Impurities on Drug Products and Medical Devices
When submitting drug products for approval, regulatory authorities frequently ask, “Are you submitting your risk assessment for...
The Big Three: Cytotoxicity, Sensitization & Irritation Testing
Among the myriad of tests that medical device manufacturers must conduct, none are more critical than the...
Successfully Execute a Nitrogen Dioxide Sterilization Validation for a Drug in a Pre-Filled Syringe
Biotech drugs are currently the fastest growing segment within pharmaceutical and biotech pipelines, with approximately 60-70% of...
Packaging Validation 101
Have you ever wondered how to set up a packaging validation according to ISO 11607? Join us...
Hunt for N-nitrosamines in Medicinal Products
In the EMA newsletter published in September 2019, the pharmaceutical industry received a significant wake-up call regarding...