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Submission of SAL for site in DMF

P

parmohan

#1
I would like to file a DMF with site sterity package details w.r.t equipments and their qualification. As per FDA guidance it falls under the DMF V category.
I need table of contents or list of documents for submission in the DMF.
can anyone help and share the same.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
For those of us following along...
DMR = Drug Master File(?)
SAL =?​
 

Ajit Basrur

Staff member
Admin
#4
I would like to file a DMF with site sterity package details w.r.t equipments and their qualification. As per FDA guidance it falls under the DMF V category.
I need table of contents or list of documents for submission in the DMF.
can anyone help and share the same.
Did you see the FDA section on Drug Master Files - it is very informative?

Drug Master Files (DMFs)

Note that effective 05 May 2017, all new DMFs must be submitted using the Electronic Common Technical Document (eCTD) format only.
 
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