I need to find a detailed guidance about risk assessment in process validation.
Assume that the excipient supplier change(like talc-lubricant)is occurred and then we need to perform validation.Should we perform full validation or can we make a risk assessment like
“Talc is used as a lubricant in this formulation. So, different brand of talc can effect dissolution of the tablet,friability(maybe),and flow of the drug mixture.Then we need to test hardness of the tablet,friability and then dissolution.We do not need to perform assay analysis for this excipient change”
Anyone knows a detailed FDA,GMP,Who or pharmacopoeial guidance on this type of assessment?
Any help will be appreciated.
thanks in advance…