Mission

To evaluate entities in the pharmaceutical supply chain for compliance with Federal and State regulations and industry best practices.

At the National Coalition for Drug Quality & Security (NCDQS), our accreditation programs evaluate wholesale drug distributors for compliance with state and federal regulations and industry best practices to maintain the quality and security of drug products. We understand the pressures involved in running a business and the needs of the industry; the importance of protecting the public from drug products that may be ineffective or dangerous due to compromised integrity or counterfeiting; and the need for a thorough and efficient process to evaluate a facility for regulatory compliance and compliance to our accreditation standards.

 

Key Aspects

Philosophy

NCDQS takes an educational approach rather than a punitive approach in working with companies through a transparent and timely Accreditation process.

Conflict of Interest

Staff and contracted surveyors/reviewers are carefully selected to prevent potential conflicts of interest. And, NCDQS does not provide paid consulting services as we believe it is a conflict of interest, and may be perceived as a requirement for accreditation.

Experienced Surveyors & Inspectors

QAS Accreditation Surveyors are either licensed pharmacists or have at least 10 years of experience specifically in wholesale drug distribution (experience may be derived from a regulatory agency or from industry). We also provide an Inspection program – our inspections are only performed by licensed pharmacists.

 

Relevancy

The industry is rapidly changing as technology becomes more advanced, new regulations are implemented and business practices evolve. Wholesale distributors are also innovative in improving the quality and efficiency of their operations. It is important that our accreditation standards remain up to date. Our standards are continuously reviewed and updated to keep pace with regulatory changes and industry best practices as well as to address emerging issues in the security and integrity of prescription and OTC products in the supply chain.

Effectiveness

NCDQS QAS accreditation programs evaluate whether applicants are compliant with regulations and implement best practices by reviewing the business and operations, key personnel backgrounds, licensure/registrations, business-critical SOPs for compliance to regulations and to our accreditation standards, and an on-site survey to assess facility security  and environmental conditions for compliance to the facility SOPs.

 

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