Address

8 The Green, Suite A Dover, DE 19901

Contact

info@ncdqs.org

(844) 80-NCDQS [(844) 806-2377]

©2019 National Coalition for Drug Quality & Security, LLC

QAS Inspection Program

The QAS Inspection Program encompasses federal and state requirements spanning business activities including the sourcing, sales and storage of pharmaceuticals. All entities that successfully complete the QAS Inspection Program verified to have proper licensing, handle and secure prescription products to protect product quality and integrity, and comply to state and federal regulations.

APPLYNOW

Submit your Pre-Inspection Application now to begin the QAS Inspection process.

 
Inspection Process Overview
  1. Facility submits Pre-Inspection Application.

  2. NCDQS QAS team will perform an inspection and provide results to facility and state agencies that request the results. 

Inspection Process Instructions
  1. Inspections are typically unannounced (not specifically scheduled). We will typically perform and inspection between 4 and 8 weeks from accepting the application.

  2. Inspections are performed during normal hours of operation.

  3. Review the standards and compare to your SOPs and business activities. Ensure SOPs are complete and that both SOPs and business activities meet all NCDQS QAS requirements and standards.

  4. Complete the application and attach the requested information and documentation. 

Standard Operating Procedures (SOP) Required
  1. Document Control

  2. Vendor Authentication

  3. Customer Authentication

  4. Product Receiving & Authentication

  5. Suspect & Illegitimate Product Detection, Handling, Investigation and Reporting

Inspection Fee Schedule
  1. Pre-Inspection Questionnaire submission: $3,000* **

*Additional fees may be incurred for deviations in Inspection process including, but not limited to, additional site visits.

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