Method Validation Protocol Review Process and Tips

Method Validation Protocol Review Process and Tips

[bharathgyadangi]

Hai sir
very nice explanation and i am implementing most of the things that you explained in my lab
Thanks for building confidence and guidance
and i have some doubts please clarify me
1. Sample reconciliation for MV activity required or not required ?
2. Is their any procedure to include in MV if something is missed in MV protocol and found during execution ?
3. For method verification what are the parameters need to consider ?
4. for dissolution method robustness with respect to dissolution parameters (variation in RPM, variation in MEDIA VOLUME and media temperature) required or not require?

[nitinpawar]

Thank you for explaining sir
It's very helpful

[dhananjayhawaldar]

Hi sir
Some times impurities not available and due time restriction we approve first protocol and impurities are available after in that case purity of impurities not available during protocol preparation.

[nagkannagi]

Sir how to prepare method qualification protocol for silver

[thehealer]

As we use finish tablets for dissolution test. While performing validation. How I use
1st is it same for both assay and dissolution accuracy for different concentration of finished tablet. As we take one tablet for each disolution vessel. for validation purpose.
How practically I use the finish tablet for the purpose

[madhuribavishetty]

Hi sir how to calculate stability failure rate in pharma

[MrKrish]

In R&D development stage spec and stp may not be available at the time of validation how to proceed? Please explain sir