Method Validation Protocol Review Process and Tips
Пікірлер: 15
@RamaKrishna-tm7pr3 ай бұрын
Explained your very well sir
@4wheels_driver8 ай бұрын
Thanks for sharing the knowledge sir
@manojmodi4142 жыл бұрын
Excellent Sir
@shilpatank1419 Жыл бұрын
Nicely explained sir, thank you
@amritarajput2597 Жыл бұрын
Thank-you very much for sharing this
@nitinpawar602 жыл бұрын
Thank you for explaining sir It's very helpful
@buddepumohanarao83092 жыл бұрын
Thank u so much sir
@muzzushaikh9628 Жыл бұрын
Thank you so much sir
@venkat5098 Жыл бұрын
thank you sir
@dhananjayhawaldar2197 Жыл бұрын
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.
@bharathgyadangi58202 жыл бұрын
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?
@sumitchangra49432 жыл бұрын
Point 4 required
@MrKrish10292 жыл бұрын
In R&D development stage spec and stp may not be available at the time of validation how to proceed? Please explain sir
@thehealer8330 Жыл бұрын
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
@madhuribavishetty5926 Жыл бұрын
Hi sir how to calculate stability failure rate in pharma