FEATURED ARTICLES
-
Trends In FDA FY2023 Inspection-Based Warning Letters
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
- Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic?
- FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
- Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
- Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems
WHITE PAPERS & CASE STUDIES
-
Correlating Stopper Height To Container Closure Integrity
Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.
-
Extractables And Leachables: Risk Management And Analytical Solutions
Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
-
Helium Leak Detection On Plastic Ophthalmic Containers
A major pharmaceutical entity wanted to ascertain their container system's seal quality. Explore results from a series of leak testing projects that highlighted key issues with their plastic containers.
-
Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing
Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.
-
Cloud-Based Serialization Solution For Various Applications
Learn about an ongoing partnership between Stegemann, a German-based contract packaging company, and a global manufacturer of production inspection systems that provides solutions for the packaging of pharmaceutical products.
-
Effects Of X-Ray Inspection On Pharmaceutical Products
Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. Explore the potential effects of x-ray inspection on pharmaceutical products and more.