How determine previous product minimum daily dosage in MACO caluculation

(Shankarsuri) #1

How determine previous product minimum daily dosage and subsequent product maximum daily dosage in MACO caluculation

(Md.Asif Hussain) #2

For calculation of MACO why the subsequent product choosen for maximum daily dose?
Thanks

(Sinem AYHAN) #3

@AsifHussain ı think your question is related with cleaning validation so it is always considered against worst case

(Dr. Ahmed Mohamed Awad) #4

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf&ved=2ahUKEwjGg-r8vd_hAhUCsXEKHQQTBaQQFjAAegQIARAB&usg=AOvVaw0mXQ25QBh8o27E8lDG8c7I

This is the link for EMA (& PIC/S) guideline for setting limits (referred to in EU &PIC/S Annex 15)

https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ema.europa.eu/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf&ved=2ahUKEwjGg-r8vd_hAhUCsXEKHQQTBaQQFjABegQIBRAB&usg=AOvVaw2drpFdjkbCSZ8N4cRdBszX

This a link for Q & A on the previous guideline published by EMA