DMF (Drug Master File) type V for Sterilization Processes for USFDA Submission

#1
Hi,
I want to file DMF type V for sterilization processes at the manufacturing facility that has 5 lines for liquid and lyophilized product.

1. Can i submit all 5 lines in the same DMF.
2. Can anyone share any list of documents to be submitted.
3. Is there any guidance for type - V submissions.
4. Procedure and required documentation for USFDA approval
5. Is there any fees for the same.

Table of content will be very helpful.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Please confirm whether this is specific to drugs or medical devices.

Thanks.
 

Ajit Basrur

Staff member
Admin
#4
Hi,
I want to file DMF type V for sterilization processes at the manufacturing facility that has 5 lines for liquid and lyophilized product.

1. Can i submit all 5 lines in the same DMF.
2. Can anyone share any list of documents to be submitted.
3. Is there any guidance for type - V submissions.
4. Procedure and required documentation for USFDA approval
5. Is there any fees for the same.

Table of content will be very helpful.
Welcome to the Cove :bigwave:

Did you refer Type V DMFs (Category 3)?

As specified in 21 CFR 314.420(a)(5), DMF holders wishing to submit a Type V DMF must obtain clearance from the FDA (See below for an exception to this requirement for sterile processing facilities). Prospective Type V DMF holders should send their request to [email protected], including the following:

1.An explanation of the necessity for filing the information in a Type V DMF
2.The proposed Subject (Title) of the DMF
3.The rationale for not submitting the information in an IND, NDA, or ANDA.
4.The clinical division that will be reviewing the information, if applicable.

Information regarding manufacturing site, facilities, operating procedures, and personnel for sterile manufacturing plants can be filed as a Type V DMF without clearance. The Subject field should specify what the DMF covers e.g., “Sterile Processing Facility.”

You can contact FDA at [email protected]. They respond very fast and I have found it very helpful.
 
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