FSMA QIC (TPP) Certification Program for VQIP
The Voluntary Qualified Importer Program (VQIP) is a voluntary program designed by the U.S. FDA to expedite the review and importation of human and animal food into the United States. Importers participating in the program can avoid unexpected delays, ensuring faster product entry. The enhanced safety and security of the supply chain benefit consumers. To qualify, importers must meet eligibility criteria and pay the FDA's program administration fee. The FSMA QIC (TPP) certification is a prerequisite for applying to the U.S. FDA’s VQIP program.
The FSMA QIC (Qualified Importer Certification) program by SGS complies with the U.S. FSMA Accredited Third-Party Certification Program (TPP) under 21 CFR Part 1, Subpart M, and the foreign supplier verification requirements for VQIP. The certification audit takes place at the foreign supplier's production site. SGS is recognized by the FDA under the Third-Party Certification Program (TPP) and accredited by the ANSI National Accreditation Board (ANAB). SGS provides FSMA QIC certification for food, beverage, and ingredient manufacturers, following preventive control requirements for human food, including seafood and juice.
The FSMA QIC (TPP) certificate is valid for one year and requires annual renewal. The audit is unannounced and consists of two stages:
Consultative audit – A review of documents and the company’s readiness for compliance.
Regulatory audit – Conducted to issue the certification.
Non-conformities are classified as Minor, Major, or Critical, with a pass/fail outcome similar to GHP and HACCP standards. FSMA QIC audits can be conducted alongside GFSI-recognized standards.
Who Should Obtain FSMA QIC (TPP) Certification?
Food and feed manufacturers who are required by customers or importers to undergo the FSMA QIC (TPP) audit for VQIP eligibility and foreign supplier verification. Additionally, manufacturers can voluntarily apply for certification to demonstrate compliance with U.S. FDA regulations, build customer confidence, and enhance market access in the United States.
Difference Between FSMA QIC, FSMA FSVP, and BRCGS FSMA Additional Module
The FSMA QIC (TPP) and FSMA FSVP certification programs are designed by the U.S. FDA under specific regulatory frameworks:
- FSMA QIC (TPP) certification is a third-party audit (21 CFR Part 1, Subpart M) for compliance with FDA requirements. It is required for VQIP participation and foreign supplier verification.
- FSMA FSVP certification is for importers to demonstrate compliance with foreign supplier verification activities (21 CFR Part 1, Subpart L).
Both FSMA QIC (TPP) and FSMA FSVP audits are conducted by Qualified Auditors to verify compliance with relevant FDA regulations, such as:
- Preventive controls for human and animal food
- Low-acid canned food and acidified food regulations
- Seafood HACCP and Juice HACCP
However, these programs do not cover Intentional Adulteration (21 CFR Part 121). The BRCGS FSMA Additional Module differs as it is a voluntary guideline developed by BRCGS to help BRCGS-certified food manufacturers understand FSMA requirements, including Intentional Adulteration (21 CFR Part 121). It is not an accredited or GFSI-recognized certification.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, safety and compliance.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and sustainability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH0002497458, Reuters SGSN.S, Bloomberg SGSN:SW).
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