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