Abd El- Halim El- Kishky

3 Questions 3 Answers 0 Followers

Questions related from Abd El- Halim El- Kishky

Does Change of supplier of the Active phamaceutical ingredient require a process validation?

I wan to know if there is a guidelines that Change of supplier of the Active pharmaceutical require a process validation of the finished product or it depends on the dosage form. On the other...

09 September 2019 6,016 3 View

Does change of the supplier of Active pharmaceutical ingredients require a process validation?

I wan to know if there is a guidelines that Change of supplier of the Active pharmaceutical require a process validation of the finished product or it depends on the dosage form. On the other...

09 September 2019 3,570 3 View

How to make statistical analysis for blend uniformity?

how to make statistical analysis of blend uniformity in process validation is it by ANOVA, Standard deviation or Process capability?

03 March 2019 4,799 3 View