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 or obtaining permitted daily exposure limits for all your pharmaceutical products, you are already behind. The regulatory agencies have been auditing both pharmaceutical manufacturers and contract manufacturing organizations on this very issue. Understand why the 10 ppm cleaning validation limit no longer applies.
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 permitted daily exposure (PDE) and acceptable daily exposure (ADE) limits calculated
- Important points to remember when determining either a PDE or ADE
- Key dates for implementation