How to register or submit drug master file to any regulatory agency?
- 2 Answers
- 6018 Views
- I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
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.
| Is This Answer Correct ? | 2 Yes | 0 No |
How to perform forced degradation on tablet sample or suspensions?
why nitrogen charecter as a inert gas plz identified
What are your duties in your current position?
What is forced degradation study?
Difference between Change control and Deviation please give the answer elaborately
1 Answers Rakshit Drugs, Smilax,
Tell us about your oncology experience.
what is the disintegration time of mouth dissolving tablet
difference between RF and correction factor?
What is the Difference between Humidity and Relative Humidity ?
What is difference between Analytical method validation and Analytical method transfer?
exolain th function of the joints
what is dossiar ? How can I submit to the regulatory department ?
Pharmacy 
