How to Evaluate Manufacturer-Provided Extractable Information


Wayland Rushing, Ph.D., EAG Laboratories; Allan R. Moorman, Ph.D., Alta Vetta Pharmaceutical Consulting

Download this white paper to understand how to evaluate manufacturer-provided extractable information.

Successful Extractables and Leachables (E&L) programs depend on accurate extractables information on the container/closure system. While many manufacturers of container/closure systems offer extractable information on their products, the usefulness of this information can vary widely from manufacturer to manufacturer and depend upon the specific formulation and usage of the Drug Product.

You will learn:

  • Definitions of extractables/leachables and their sources
  • Regulatory requirements for E&L evaluations
  • The right questions to ask your vendor regarding contact materials
  • How to perform risk assessment and gap analysis on the data
  • Commonly observed gaps in manufacturer-provided data

This white paper also includes two case studies illustrating the importance of evaluating manufacturer-provided extractable data.

By starting the extractables and leachables evaluation early, sponsors can avoid potential delays in their development time line, avoid recalls and, most importantly, avoid jeopardizing patient safety.

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