QA/QC & Analytical Techniques In-Depth Focus 2020
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacurers with guidance.
- NDMA: a recall trigger for the drug development industry
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
- Release of sterile medicinal products – looking at the focal points
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.