National Coalition for
Drug Quality & Security
Mission
To evaluate entities in the pharmaceutical supply chain for compliance with Federal and State regulations and industry best practices.
We understand the operational complexity of the pharmaceutical industry and embrace the importance of protecting the public from drug products that may be ineffective or dangerous due to diversion, compromised integrity, or counterfeiting. Our process to evaluate a facility for regulatory compliance and adherence to our accreditation standards is thorough and efficient.
Key Aspects
Philosophy
NCDQS takes an educational approach rather than a punitive approach in working with companies through a transparent and timely QAS Accreditation or QAS Inspection 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. All inspections are performed by licensed pharmacists that have been specifically trained on NCDQS Standards.
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Experienced Surveyors and Inspectors
Our Surveyors and Inspectors for accreditation 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.
Adapting to Today's Landscape
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
The NCDQS QAS accreditation program evaluates 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.