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.
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Thanks well explained & logical reply.
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Well replied.
Adequate ventilation, air filtration and exhaust systems should be provided for excipients as well API dispensing process. IH systems should be designed and constructed to minimize risks of contamination and cross-contamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate
to the stage of manufacture. Particular attention should be given to areas where APIs are
exposed to the environment so an intra/Inter/external auditor could show risk assessment approach periodically risk score card as indicating method. i.e. Bio hazard, toxic chemical, fuming liquid , narrow therapeutical index API etc. always concern as its involve risk identification to human being.