Presenting our FREE eBook:

Understanding the European Medicines Agency’s Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Complete your name, company name, and e-mail address to instantly download.

On June 1st, 2015, the European Medicines Agency’s “Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” went in to effect for newly introduced human pharmaceutical products in a multi-product pharmaceutical manufacturing facility.

If your company has not been preparing for this new regulatory requirement, you are already behind.

In this easy to read, 15-page publication prepared by Affygility Solutions, you will learn the following:

  • Why are health-based exposure limits necessary
  • What compounds require dedicated facilities
  • How are PDEs and ADEs calculated
  • Important points to remember when determining either a PDE or ADE
  • Key dates for implementation
  • References

Created by the potent compound safety experts at Affygility Solutions.

Need an acceptable daily exposure (ADE) or permissible daily exposure (PDE) value for your generic pharmaceutical product? Then check out OEL Fastrac today!