Third Party Audit Guidance FDA

May 6, 2017
Third Party Audit Guidance FDA
This guidance is intended to assist industry and the Food and Drug Administration (FDA) staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The guidance serves as a companion document to the implementing regulations in 21 CFR parts 1, 11, and 16 that establish the framework, procedures, and requirements for accreditation bodies and third-party certification bodies for this program.