Thank you for the detailed explanation sir, I would request you to make a presentation on different types of stalactitical terms viz:95% CI, p Value, and two-sided t-tests and control charts with examples related to the pharmaceutical industry.
If root cause is not identified by phase 1 and phase 2... With unidentified root cause... If we release the batch by statistical evaluation, but why OOS was happened ? this question remains the same as it is... Then how we can conclude all these things, because we still don't have any root cause..... Will FDA accept this... Plz do consider this question and guide us...🙏
if assignable cause is not identified, one can define the probable root cause - go with additional testing... This approach is accepted by both MHRA and USFDA.
Yes, FDA accept for no rot cause senecio in isolated cases but not in all cases.You must check the other variabilities, stability, Fad data, product history and make a conclusions. It does not mean only statistical approach is suffice to relapse the batch and have to consider and Irene facts and batch have to load on stability also.
Excellent video sir
❤😊 thanq sir...
Thank you for the detailed explanation sir, I would request you to make a presentation on different types of stalactitical terms viz:95% CI, p Value, and two-sided t-tests and control charts with examples related to the pharmaceutical industry.
If root cause is not identified by phase 1 and phase 2...
With unidentified root cause... If we release the batch by statistical evaluation, but why OOS was happened ? this question remains the same as it is... Then how we can conclude all these things, because we still don't have any root cause..... Will FDA accept this... Plz do consider this question and guide us...🙏
if assignable cause is not identified, one can define the probable root cause - go with additional testing... This approach is accepted by both MHRA and USFDA.
Yes, FDA accept for no rot cause senecio in isolated cases but not in all cases.You must check the other variabilities, stability, Fad data, product history and make a conclusions. It does not mean only statistical approach is suffice to relapse the batch and have to consider and Irene facts and batch have to load on stability also.
Can we apply these 2 criteria (95% CL, % RSD) for microbiology also...