Ophthalmic OTC Product

Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy requires certain OTC ophthalmic products sold in the U.S. store to undergo third-party verification through an approved Testing, Inspection and Certification (TIC) provider. When SGS is selected as the TIC provider, the process may include:

1. Product testing and review: Sellers select SGS as an approved TIC provider to complete the applicable regulatory, documentation, and testing requirements for the ASIN.
2. Good Manufacturing Practice (GMP) Certificates: SGS reviews acceptable evidence of Good Manufacturing Practice (GMP) compliance for the manufacturing facility.
3. Label Verification and Product Testing: SGS reviews the product label and claims, applicable OTC monograph or NDA/ANDA pathway, FDA National Drug Code (NDC) listing, USP <71> sterility testing, and tamper-evident packaging requirements, as applicable.

Phase 1 - Regulatory, Label, NDC and GMP Review

• Review of the product label and claims, active ingredient, and applicable OTC monograph or NDA/ANDA pathway.
• Review of GMP documentation and manufacturing-facility compliance.
• FDA NDC listing verification and confirmation that the NDC corresponds to the product being evaluated.
• 
  Completing the regulatory, label, NDC and GMP review first helps identify issues before the more time-intensive USP <71> sterility testing begins.

Outcome of Phase 1:

• If the applicable Phase 1 requirements are satisfactorily addressed, the product proceeds to Phase 2.
• If issues are identified, SGS will advise on the appropriate next steps before Phase 2 begins.

Phase 2 - Sterility and Tamper-Evident Packaging Verification

• Phase 2 includes sterility testing in accordance with USP <71> and tamper-evident packaging verification in accordance with 21 CFR 211.132.
• Objective: Complete the applicable sterility and tamper-evident packaging requirements before the final verification result is submitted.
• Cost Consideration: USP <71> sterility testing is more time-intensive and costly than many other verification tests, so SGS completes the Phase 1 review before proceeding. This helps avoid unnecessary sterility testing costs and delays when an issue is identified earlier in the review.

Why SGS Uses a Two-Phase Approach:

• The phased approach allows potential regulatory, labeling, NDC, or GMP issues to be addressed before the seller incurs the cost and longer turnaround time associated with USP <71> sterility testing.
• Outcome notification: Once all applicable requirements have been evaluated, SGS submits the verification result through Amazon’s required compliance process. A passing verification supports the product’s eligibility for sale; Amazon retains control over the listing and final marketplace status.

As an Amazon Selling Partner, Amazon will notify you if your product requires compliance verification. Follow the Amazon process for requesting verification services, typically through your Seller Central Portal, which will allow a Selling Partner to select an approved Testing, Inspection and Certification (TIC) provider. Once you select SGS, our team will contact you regarding the documentation, product information, samples, and next steps needed to begin the verification.

Per Amazon's Over the Counter (OTC) Ophthalmic Products Program Policy, product-compliance status is valid for one calendar year from the verification pass date. Amazon may issue a re-verification request when a new verification is required. If the compliance status of a product expires, Amazon may suppress the ASIN (product listing), until valid compliance status is restored.

To renew compliance, you will need to complete the applicable re-verification process through an approved TIC provider such as SGS to ensure the product still meets Amazon safety and quality standards.

Sample quantities depend on the product and testing required and will be confirmed during the quoting and review process. Samples submitted for testing must be unopened, sealed, and representative of the product as sold.

Timing depends on both documentation review and laboratory testing. Once Phase 1 is satisfactorily completed and the required samples are received by the laboratory, the USP <71> sterility-testing portion typically takes approximately four weeks. The overall verification timeline may vary based on documentation completeness, laboratory scheduling, manufacturer or laboratory follow-up, and any Out-of-Specification (OOS) investigation or remediation that may be required.

Verification costs depend on the product and the services required. SGS uses a phased approach so the applicable regulatory, label, NDC, and GMP requirements can be evaluated before the seller incurs the cost of USP <71> sterility testing. Please request a quotation for pricing specific to your product.

If a product does not meet one or more applicable requirements, SGS will identify the noncompliant parameter(s) and advise whether Amazon’s policy provides an available resolution pathway. Some findings may be eligible for remediation, while others may not. If SGS and the Selling Partner reach an impasse regarding the verification or resolution process, the Selling Partner may appeal directly to Amazon.

If your product qualifies for failure resolution, the selling partner must submit a Corrective and Preventive Action (CAPA)document to SGS, addressing the root cause, corrective actions, preventive actions, and implementation timeline, where a CAPA pathway is available. Not every failure has a resolution pathway. For eligible failures, SGS will explain the available next steps, which may include additional review, documentation, or testing. Additional fees may apply.

Amazon requires SGS to confirm that supporting testing and certification documentation is authentic and meets the applicable program requirements. Where possible, SGS may authenticate documentation using an official database or website maintained by the issuing organization. When public verification is not available, SGS may need to obtain confirmation directly from the laboratory, certification body, manufacturer, or other issuing organization.

Potentially. Amazon allows SGS to review certain existing third-party test documentation when the testing and laboratory meet the applicable requirements. Among other criteria, the laboratory must have appropriate ISO/IEC 17025 accreditation covering USP <71> or an equivalent method, the testing must meet the program requirements, and the testing must generally have been completed within six months before submission to SGS. SGS must also be able to authenticate the documentation.

If existing testing does not meet the applicable requirements, additional testing may be needed.