Nitrosamines and related compounds continue to be a hot topic among regulatory agencies globally.
Regulators are asking drug product manufacturers to identify products at risk of N-nitrosamine formation or contamination, which could impact the pharmaceutical industry supply chain.
This webinar provided an update on regulatory expectations for assessing, testing and reporting of nitrosamines and/or their potential formation in drug products. In addition, the webinar included best practice strategies and examples for ongoing communication between excipient suppliers and users.
Attendees were provided with:
> Background and overview of regulatory expectations relative to excipients, including a review of regulatory changes in the past 12 months
– Need for drug product manufacturers to complete testing for nitrosamines in their drug products based on risk assessment outcomes
> Discussion of additional support that may be requested from excipient suppliers, based on confirmatory test results
– Potential supplier response to user needs (based on IP, capabilities, competitive intelligence, etc.)
> Options for excipient users to use information obtained from their excipient supplier in the identification of products at risk of N-nitrosamine formation or contamination
– Tips for effective communications between excipient suppliers and users
– Feedback from users on what has worked well vs what has been a challenge
> Proposed best practices and strategies for ongoing communication between excipient suppliers and users
– information required for new excipients
– information needed when current excipient information changes
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs