Phase III/Post-Commercialisation Changes: Extractable and Leachables Considerations for Container Closure Systems

Introduction After a drug product has gained authority approval many changes can occur during the life of the product. Most changes pertaining to the Chemistry, Manufacturing, and Controls (CMC) portion of the dossier will need to be submitted for post approval when changes are made. Such changes m...

To read the full article and other articles in this issue, please register for a free account or log in.

We will not sell or give your information to a third party. See our Privacy Policy



Subscribe to our FREE newsletter

We will not sell or give your information to a third party. See our Privacy Policy