FSMA - VQIP

Best ISO got the First FDA Accredited Third-Party Accredited
Certification Program: Public Registry of Accredited
​Third-Party Certification Bodies in Asia​

Issue the first fda fsma vqip certificates.

FSMA - VQIP
The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers. Both consumers and importers will benefit from this program.
Participating importers will be able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers will also benefit from the importer’s robust management of the safety and security of their supply chains.
To participate, importers must meet eligibility criteria and pay a user fee that covers cost associated with the FDA’s administration of the program.

The U.S. Food and Drug Administration (FDA) will be opening the Voluntary Qualified Importer Program (VQIP) application portal on October 1, 2018. This will allow importers to submit their completed applications early for the FY20 benefit year. Importers interested in applying can start their application by submitting a notice of intent to participate by setting up an account via the FDA Industry Systems website. Once you have an account, selecting VQIP under the FSMA Program options will take you to the VQIP Application Page with an option for submitting a Notice of Intent to Participate. Importers applying for the FY20 benefit period may wish to refer to the Step-by-Step guide  as they prepare their applications.


These certifications are used for two purposes.
  • Certifications can establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.
  • In rare and specific circumstances FDA can require that an imported product be certified to prevent a potentially harmful food from entering the U.S. 
 The Agency’s imported food goal is twofold:
  • To address potential safety issues before the food reaches the United States; and
  • To help ensure that imported foods are produced in accordance with the same safety standards as those required of U.S. foods.
Accreditation bodies under the Accredited Third-Party Certification Program must:
  • Assess third-party certification bodies to determine if they can be accredited. This includes observing a representative sample of the applicant’s work;
  • Monitor the performance of the certification bodies it accredits. Accreditation bodies must notify FDA of any change in, or withdrawal of, accreditations it has granted;
  • Assess and correct any problems in the accreditation body’s own performance;
  • Submit monitoring and self-assessment reports and other notifications to FDA;
  • Maintain and provide FDA with access to the records that the program requires.

FDA’s Accredited Third-Party Certification Program was established under the FDA Food Safety Modernization Act (FSMA). It is a voluntary program that allows “accreditation bodies” to apply for recognition by FDA. Recognized accreditation bodies will have the authority to accredit third-party Certification Bodies.

Application
1.0  All clients need to delivery the following application information before the audit scheduling.
  1. Contract
  2. Application form ( Attachment A form 1)
  3. Questionnaire-EH1 for FDA ( Attachment B- Form 2-8  )
  4. Food safety plan  issued by qualified person PCQI
  5. FSMA - Quality manual ( Not requirement)
  6. Evidence in compliance with applicable food safety requirements of the FD&C Act and FDA regulations
  7. Previous FDA relative information
2.0 And understanding the following requirements for the special BEST ISO-IAS-FDA FSMA requirement.
  • All the audit must be conducted without announcement during the 30-day timeframe identified.
  • ST1 readiness audit to verify the system and the all that minimum man day is one man day, must be focused on determining whether the facility, its process(es), and food are in compliance with applicable food safety requirements of the FD&C Act and FDA regulations, ( attachment C) 
  • ST2 will follow the man day form ( attachment D) for an onsite audit for (IAS 4.10.2) examination of the facility, its process(es), and the food that results from such process(es);and where appropriate or when required by FDA, environmental or product sampling and analysis. When, for a regulatory audit, sampling and analysis is conducted, the accredited third-party certification body must use a laboratory that is accredited in accordance with paragraph of this document 1.8. above. The audit may include any other activities necessary to determine compliance with applicable food safety requirements of the FD&C Act and FDA regulations, and, for consultative audits,also includes conformance with applicable industry standards and practices. (1.12)ISO9001 with HACCP or ISO22000 (IAS-4.10.3.) The audit must be sufficiently rigorous to allow the accredited third-party CB to determine whether the eligible entity is in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and for consultative audits, also includes conformance with applicable industry standards and practices, at the time of the audit; and for a regulatory audit, whether the eligible entity, given its food safety system and practices would be likely to remain in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations for the duration of any certification issued under this accreditation program. An accredited third-party CB that identifies a deficiency requiring corrective action may verify the effectiveness of a corrective action once implemented by the eligible entity, but must not recommend or provide input to the eligible entity in identifying, selecting, or implementing the corrective action.

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