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?

Explained your very well sir

Thanks for sharing the knowledge sir

Thank-you very much for sharing this

Thank you for explaining sir It's very helpful

Nicely explained sir, thank you

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.

Excellent Sir

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

Thank you so much sir

thank you sir

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

Thank u so much sir

Hi sir how to calculate stability failure rate in pharma