National Coalition for
Drug Quality & Security
Quality and Security (QAS) Accreditation
The Quality and Security (QAS) Accreditation Program encompasses federal and state requirements spanning key business activities including the sourcing, sales and storage of pharmaceuticals. Companies that are accredited by NCDQS are verified to have proper licensing, appropriately source, handle and secure prescription products to protect product quality and integrity, verify vendors and customers, and comply to state and federal regulations including reporting requirements.
Accreditation Process Information
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Standard accreditation is 3 years.
Timeline
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We are able to grant Accreditation in 90-days due to our innovative approach. Facilities that have not achieved accreditation will be given detailed information regarding the areas of non-compliance so that they may remediate any issues identified within their operation..
Accreditation Process Instructions
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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.
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Complete the application and attach the requested information and documentation.
Supplemental Documents Required
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Organizational chart
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Description of positions on the organizational chart
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Vendor List (Contract Manufacturers, 3PL, etc.)
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License List
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Table of Contents of the Policy and Procedures
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Table of Contents of the Employee Handbook
Standard Operating Procedures (SOP) Required
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Document Control
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Vendor Authentication & Oversight
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Customer Authentication
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Suspicious Orders
Accreditation Fee Schedule
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Accreditation Application submission: $1,000* **
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Annual Review, beginning of Year 2: $2,500
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Annual Review, beginning of Year 3: $2,500
Total for Accreditation + Inspection for "virtual manufacturers" is $10,000.
* $4,000 QAS Inspection is required for Accreditation application.
**Additional fees may be incurred for deviations in Accreditation process including, but not limited to, additional site visits.
