Many excipientsuppliers are using the IPEC Questionnaire for Excipient Nitrosamine Risk Evaluation to conduct nitrosamine risk assessments. Does FDA accept prepared questionnaires,such as the one developed by IPEC, as a valid risk assessment tool?

Root Causes Excipients
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This and more questions related to Impact and Harmonization on this document recently published by FDA from a recent FDA-Industry meeting AAM/CHPA/PhRMA May 4th

QA Written Responses_Joint Industry Group Meeting on Nitrosamines_final.pdf (133.3 KB)

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