EandL Assessment of Material Changes eBook

What is in the eBook?

During the lifecycle of a drug product, there are likely to be a number of changes to the materials or components used to manufacture and store it.This is especially true when the manufacturing processes involves single use components.

This white paper considers the key factors when undertaking material changes, including;

  • Types of material changes and when they occur
  • Definition of risk as it relates to extractable and leachable compounds
  • Types of studies which assess materials and help us understand risk

Download the eBook