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Dedicated Area for Anti TB Products

Hi all,

Is there any requirement for dedicated area for Manufacturing of Anti TB Products?

Please clarity me.

[quote=vamsemicro]Hi all,

Is there any requirement for dedicated area for Manufacturing of Anti TB Products?

Please clarity me.[/quote]

hi vamsemicro,
as far as i am concerned there is no such restriction. they can be manufactured in any area. only problem is with Rifampicin which is red in colour and very difficult to clean. only because of this the area is kept seperate rather there is no other reason. so the area must be dedicated to rifampicin one drug in Anti T.B category other drugs can be manufacutred in any area.
tho’ consideration is that of u r able to clean the drug from the area as per ur cleaning validation criteria when used in same area for manufacturing other products (other than Anti TB) filter replacement is a must as it is difficult to clean.
any other comments from our fellow friends is highly appreciated
cheers
astute