Submission of SAL for site in DMF

P

parmohan

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.
 
Marc

Marc

Fully vaccinated are you?
Leader
For those of us following along...
DMR = Drug Master File(?)
SAL =?​
 
Ajit Basrur

Ajit Basrur

Leader
Admin
parmohan said:
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.
Click to expand...

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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