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How to register or submit drug master file to any regulatory agency?
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Answer / mukesh tiwari
For ANDAs or US Market: One Exhibit or validation batch and
3M stability data.
For EU :Three Exhibit or validation batch and 3 M stability
data. And other supporting documents such as Pre-process
validation protocol and reports, cleaning validation, hold
time study of Bulk, Initial PQ and current one etc.
| Is This Answer Correct ? | 4 Yes | 0 No |
for the register or submit THE DMF of Any TYPE for any regulatory you have to prepare a DMF as per the guideline of the particular regulatory where you wish to submit DMF.
You may get guideline via Internet
for us open pg WWW.USFDA.GOV and search DMF guideline.
and you have to hire a one agent for that.
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