GMP: New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation

The draft Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, published in January had already been discussed conclusively by EMA\'s Safety Working Party in December 2012. The new Guideline became necessary because of the more scientific approach of the Chapters 3 and 5 in the EU GMP Guideline.