Regulatory Open Forum

Hello,

I have a question regarding compliance to USP 467.  If the supplier tests the API for USP <467>  Class 3 and results conform to USP <467>. Is the DP manufacturer required to test the API for residual solvents to confirm residual solvent levels match the COA?  The supplier is qualified and no residual solvents are used to manufacture the drug product.  We will not test the DP. Testing question is specifically for the API. 

Thanks in advance,
Olga