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DMF project

Written by Zdravko Mauko

Tuesday, 03 January 2006

Timeframe for DMF development

Timeframe to development and submission of DMF is 8 to 9 months. In some cases when you have an experienced project team and when you are in a hurry timeframe could be squeezed to 4 months.

Subject: time frame for DMF
From: "Ashish"
Date: Mon, 2 Jan 2006 14:42:50 +0000

Hi to all forum members,

Can anybody help me constuct a time frame chart (Gantt Chart)
for DMF filing in US,EU and Japan i.e. where ICH guidelines are to be followed.
More specific, wishes to compare the time required in performing and
arranging the data for the activities for DRUG SUBSTANCE like
- Physical and chemical characteristics
- Elucidation of structure
- Stability
- Process controls
- Specification and analyical methods

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Hi Ashis
Time frame for DMF depends mainly about stability testing because this is the longest activity on the critical path of the DMF project.
First, you should develop stability indicative analytical methods. Then you will need 6 months for actual stability testing according ICH guidelines. Then you will need about one month for stability report and compilation of DMF. All other activities should be placed into this timeframe and made in parallel with stability testing.
According to my experience, timeframe to development and submission of DMF is 8 to 9 months. In some cases when you have an experienced project team and when you are in a hurry timeframe could be squeezed to 4 months. This is possible in some cases when national health authorities (FDA) will accept results of 3 month stability testing with statement that full stability report will be submitted after additional 3 months.

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