How WPRX Ensures Transparency and DSCSA Compliance
Westminster Pharmaceuticals (WPRX) is proud to be a leader in regulatory compliance and transparency. We go beyond basic requirements to ensure the highest safety and efficacy standards in our generic medications. Every medication that comes from us can be tracked, verified, and trusted throughout its journey to the patient.
Drug Supply Chain Security Act (DSCSA)
As the November 27, 2024, stabilization period deadline approaches, pharmaceutical companies are finalizing their systems to meet enhanced DSCSA requirements. The digital transformation of this final phase marks a significant shift in how the entire supply chain must operate.
WPRX has positioned ourselves ahead of these requirements, having already implemented comprehensive electronic tracking and serialization processes. Each prescription drug package in our system carries unique serial numbers that integrate seamlessly with our trading partners' systems, enabling efficient data exchange throughout the supply chain journey.
WPRX's Comprehensive Compliance Framework
A rigorous approach to FDA regulations is the foundation of WPRX's compliance efforts. Each new product undergoes extensive registration processes, including filing ANDAs and registering every National Drug Code (NDC) with the FDA to ensure all medications are recognized and approved for distribution.
We also conduct annual audits and quarterly product reviews so our operations consistently meet the critical standards outlined in CFR parts 210 and 211 for current good manufacturing practices (cGMP). Our commitment to excellence is further demonstrated through mandatory annual cGMP compliance training, which keeps the team current with laws and regulations governing drug production.
Serialization and Supply Chain Security
WPRX utilizes advanced SAP/ATTP software to ensure comprehensive product serialization, enabling precise tracking in the supply chain from production to pharmacy shelves. This sophisticated system prevents counterfeit drugs and maintains product authenticity. Led by our contract compliance team, the vendor reporting and serialization process includes creating unique serial numbers and tracking all items to maintain DSCSA compliance.
Vendors promptly receive specialized data for all incoming shipments, and this critical information is consistently verified to ensure complete product traceability while maintaining the highest standards of service for our partners.
WPRX's commitment to supply chain security is further strengthened through our partnership with Direct Customer Solutions (formerly R&S Solutions). Their state-of-the-art fulfillment and distribution center features robotic technology, refrigeration capabilities, and an enhanced security vault. This advanced infrastructure provides care, safety, and consistency for all products throughout the supply chain journey while preventing tampering.
Quality Assurance and Pharmacovigilance
Another critical component of transparency and compliance is protecting patients from counterfeit drugs and reporting any issues with complete transparency to protect the integrity of our supply chain. We maintain a robust pharmacovigilance and quality assurance system to monitor and respond to safety concerns, with all adverse effects or product issues tracked and disclosed to the FDA immediately.
The WPRX Advantage
What truly sets WPRX apart is our personalized approach to compliance and transparency. Unlike larger organizations where customers might get lost in automated systems or call centers, WPRX provides direct, personal attention. When customers or partners call with inquiries, they speak directly with experts. Calls are returned within hours, not days, and every concern receives immediate, expert attention.
The company's rapid response protocols extend beyond customer service to include all compliance and safety monitoring aspects. Whether it's tracking serialized products, ensuring the interoperability of our data throughout the supply chain, or providing full vendor transparency, WPRX's proactive approach means we’re never playing catch-up with regulations. We’re ahead of the pack, ensuring seamless integration of compliance requirements without interrupting our partnership operations.
WPRX's commitment to transparency benefits all our supply chain partners. Pharmacies gain peace of mind knowing they're working with a company that prioritizes compliance and patient well-being. Distributors benefit from clear, consistent communication and reliable tracking systems. Most importantly, patients receive safe, effective medications backed by comprehensive quality assurance and safety monitoring.
Contact us to learn more about our transparency and compliance, or become a Westminster Pharmaceuticals partner.
