QbD

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi,
Could any one please elaborate the QbD concept with any one example.

Thanking you…

2

Hi find the below link from fda which shall be helpful

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM304305.pdf