Separate Dispensing Area for Active & Excepients

These day during audits Inspectors demand separate sampling area and dispensing area for Both API & Excepients. Is there any guideline or Draft Notification about it.

There is no specific guideline on this aspect.
You can have a common area/booth for sampling and dispensing of API and excipients together.
You can take administrative measures through in-house SOP to control these activities such as dispensing excipients first and then API to avoid cross-contamination. Have dedicated scoops, spoons, devices for each type of APIs, and excipients to avoid cross-contamination.
However, you should have separate areas for sampling/dispensing of solvents, toxic chemicals, and fuming liquids. This is from safety and toxicity point of view. For such materials (Solvents & fuming liquids) a well-designed air handling and exhaust system is required to expel the fumes of these materials.


Thanks well explained & logical reply.

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Well replied.