Accredited Third Party Certification Program was established under FDA’s FSMA (Food Safety Modernization Act). It is a voluntary program in which FDA recognizes accreditation bodies that will have the responsibility of accrediting third party certification bodies. Such certification bodies will conduct food safety audits and issue certifications to foreign food facilities. A certification body will conduct two kinds of audits: Consultative and Regulatory. A consultative audit will help foreign facilities prepare for a regulatory audit. If a regulatory audit determines that the facility is in compliance with US food safety requirements, the facility is awarded with a certification.
A certification body is required to report to FDA results of both types of audits immediately if serious risk to public health is predicted.
The certifications obtained through FDA’s Accredited Third-Party Program serves two purposes:
- Importers can use a certification to establish eligibility to participate in Voluntary Qualified Importer Program (VQIP)
- FDA can require certification as a condition of entry for specific imported food products.
An accreditation body has the followed duties under the Accredited Third-Party Certification Program:
- Assess third party certification bodies competence if they can be accredited.
- Monitor the performance of certification bodies it accredits and notify FDA of any change in their status.
- Submit all data regarding certification bodies and its own performance to FDA
A certification body has the following duties:
- Ensuring audit agents competence
- Verify a facilities food safety plans effectiveness
- Submit all data required by the program and report of its own performance to FDA.
Foreign governments, agencies or private third parties may apply to become accreditation bodies as well as certification bodies.
Requirements to become an Accreditation or Certification body:
- Authority to assess third party for accreditation or conduct site audits and review records
- Competency to have adequate finances, skills, resources and experience for operation.
- A written quality assurance plan
- Written measures to protect against conflicts of interest
- Written procedures to establish, control and retain records.
FDA will post a notification on its webpage every time it recognizes an accreditation body and also when a certification body is accredited.
In March 2019, FDA’s accreditation body ANSI has accredited two third party certification bodies: SGS North America Inc of Rutherford, NJ and NSF Certification, LLC of Ann Arbor.
Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on April 10, 2019
Will an accredited body help me with GMP certification? I want to be ready in case FDA comes for inspection. Thank you!
During an inspection, FDA checks for a food facility’s compliance to GMP. A certification is not required by FDA. But any accredited body can be approached to obtain a certificate.