The highly anticipated new guide published by the European Medicines Agency (EMA) defines the exposure limits for items produced by custom manufacturers.
In other words, to what extent can you manufacture two products in the same container without posing any risks to the patient? The most recent document dealing with this subject dates back to January 2013. This new text introduces one major change: it is now possible to deviate from the general procedure for establishing limits, if this modification is duly justified. The procedures for calculating limits (acceptable daily exposure) remain unchanged.
Source : www.processpropre.com