Our QAS Inspection​ program covers facilities with business models including, but not limited to, the following:

• Prescription drug manufacturers (distribution activities only, not cGMP)

• Virtual manufacturers (distribution activities only, not cGMP)

• 503B Outsourcing facilities (distribution activities only, not cGMP)

• Prescription drug wholesalers

• Medical Gas Distributors (distribution activities only, not cGMP)

• Medical Device Only Distributors and  Manufacturers (distribution model only)

• Reverse Distributors

• Drug Repositories

• Specialty wholesalers

• Virtual wholesale distributors

• OTC wholesalers

• OTC-only wholesalers

• Medical device wholesalers

• Veterinary wholesalers

• Third-party logistics (3PL) providers (for prescription products, OTC and OTC only, medical devices, veterinary, etc.)

• Clinical Trial Phase 2 Product Distributors

• The Facility has a free informational call to determine best way to proceed. This call may be scheduled through Calendly. (link here)

• Facility submits the Online QAS Inspection by NCDQS Application and attaches the requested information and documentation.                           (Link to application)

• Paying the application fee submits the application. If you need to pay the fee via invoice, please email us at info@NCDQS.Org so we may generate an invoice and send it to you.

• NCDQS will review materials before reaching out to schedule an Intake Call.

• NCDQS and Applicant will schedule an Intake Call. And coordinate an inspection date, typically 4-6 weeks after submission of payment.

• NCDQS will perform the Inspection, and inspector will review any partially compliant or non compliant findings with the facility.

• The Inspection report is reviewed by our central review committee.

• A Remediation plan will be created as appropriate and sent to applicant.

• NCDQS will provide the Inspection Report to the applicant.

• NCDQS will provide Inspection Reports to state agencies directly, only if requested by applicant in writing. 

• Inspections are unannounced (i.e. not scheduled with the facility). Note: A window of one or two weeks may be provided, the inspection will still be unannounced within this window.

  • Inspections for virtual entities that do not take possession of product will be announced and scheduled due to the remote nature of their business.

• We are typically able to perform an inspection between 4 and 6 weeks from accepting the application and holding the Intake Call.

• Expedited inspections may be performed if inspectors are available within 30 days of application and payment submission.  Expedited inspections will incur a $500 expedited travel fee which will be invoiced separately.

• Inspections are performed during normal hours of operation, and not on holidays or weekends.

• Reports are reviewed onsite at the end of the inspection and a preliminary action plan will be suggested by the inspector. The report will then undergo an internal review for content and accuracy and then be sent to the facility within 3 days to 1 week after the inspection.

• Pre-Inspection Application submission flat fee: $4,000*   *

• NCDQS inspector travel expenses are already included in the flat fee. 

• Expedited Inspection rested within 30 days of submission will incur $500 additional fee.

• *Additional fees may be incurred for deviations in Inspection process including, but not limited to, additional site visits, or facilities located in Hawaii or Alaska.

• **Inspection Fee is non-refundable unless site visit is not performed. If site-visit is not performed, Applicant will be refunded $2,000 site visit fees.

• Colorado

• Iowa*

• Kansas

• Maryland

• Mississippi

• Nebraska

• New Hampshire

• South Carolina

• South Dakota

• Tennessee *Out of state 3PL require accreditation

• Utah

• Vermont

• Washington

• Wyoming*

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Additional states have informally accepted QAS Inspection reports.

*Accreditation may be required.