ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 4.4: Use dedicated production areas for highly sensitising materials such as penicillins and cephalosporins, consider them for highly potent or infectious materials, and keep toxic non-pharmaceuticals out

What does 4.4 require?

Dedicated production areas (facilities, air handling and process equipment) should be used to make highly sensitising materials such as penicillins or cephalosporins. Dedicated areas should also be considered for infectious, highly pharmacologically active or toxic materials (for example some steroids or cytotoxic oncology agents) unless proven inactivation or cleaning procedures are in place and kept up. Measures should prevent cross-contamination from people and materials moving between dedicated areas. Very toxic non-drug materials such as pesticides and herbicides should not be produced, weighed, milled or packed in buildings or equipment used for APIs, and should be handled and stored apart from APIs.