P
parmohan
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.
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.