Where N-Nitrosamine Assessments for Drug Products Meet Extractable / Leachable Qualifications for Pharmaceutical Primary Packaging

Recently there have been a number of drug product recalls due to the unexpected presence of N-Nitrosamines. While in most of those cases, N-Nitrosamine formation occurred at the level of the drug substance synthesis and stability, it is well known and documented that some materials, used in primary packaging can also be a source for NNitrosamine contamination of the packaged drug product (e.g. older grade elastomers and nitrocellulose laminated blister foils). 

The unanswered question is: do we know everything about the materials of construction of a container closure system and their ability to generate N-Nitrosamines? This presentation will offer insights into how an integrated approach for the N-Nitrosamine risk evaluation for a pharmaceutical container closure system could look like.