Compliance champions: Why pharmacies choose our regulatorily approved generic medications
Pharmaceutical compliance isn't just a requirement—it's the foundation of trust and safety. Westminster Pharmaceuticals (WPRX) stands out as a leader in regulatory compliance and a trusted pharmacy supplier, ensuring all our products meet the highest safety and efficacy standards. Our commitment to compliance provides pharmacies with peace of mind, knowing that they are dispensing safe and effective medications that adhere to rigorous regulatory standards.
The Importance of Generic Pharmaceutical Compliance
Generic medications play a vital role in healthcare by offering affordable alternatives to brand-name drugs. However, the lower cost does not mean a compromise in quality or safety. The regulatory landscape surrounding generic drugs is just as stringent as that for branded medications.
At WPRX, we understand the critical nature of compliance in the pharmaceutical industry. We maintain the highest standards in all business operations, from manufacturing and packaging to distribution and beyond. Pharmacies that partner with WPRX can trust that our generic medications are fully compliant with all applicable regulations to protect the safety and well-being of their patients.
Regulatory Compliance
We understand that pharmacies trust us because of our ability to meet and exceed stringent regulatory standards. This commitment is reflected in every aspect of our operations, from the registration of our products to the ongoing training of our team.
FDA Registration and NDC Compliance
Each new product we bring to market undergoes a rigorous process to ensure compliance with FDA regulations. This includes registering every National Drug Code (NDC) with the FDA, a crucial step that ensures our medications are recognized and approved for distribution.
CFR 210 & 211 Compliance
The FDA's Code of Federal Regulations (CFR) parts 210 and 211 set forth guidelines for current good manufacturing practices (cGMP) in drug production, processing, packing, and storage. At WPRX, we conduct annual audits and quarterly product reviews to ensure our operations consistently meet these critical standards.
Serialization and DSCSA Compliance
We utilize advanced SAP/ATTP software to ensure every product is serialized, enabling precise tracking from production to the pharmacy shelf. This level of traceability is vital for preventing dangerous counterfeit drugs from entering the supply chain and ensures that our products are safe and authentic.
Annual cGMP Compliance Training
Regulatory compliance standards and regulations are constantly evolving. To stay ahead, WPRX conducts annual cGMP compliance training for our team so we’re always up-to-date on the latest laws and regulations governing drug production. While the FDA mandates these GMPs, we go beyond mere compliance, using them to continuously improve our products, operations, and overall company practices.
The Role of Our Pharmacovigilance Team
One of the cornerstones of our compliance efforts is our dedicated pharmacovigilance team, led by our expert, Olga Sanchez. Pharmacovigilance refers to monitoring the safety of medications after they have been released on the market. It involves detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem.
Olga Sanchez brings decades of experience to her role, offering a unique perspective as a tenured medical professional with firsthand experience in patient care as a registered nurse with her Masters of Science in Nursing (MSN).
We don't just react to reports of adverse effects; we proactively engage with healthcare providers, patients, and pharmacies to gather feedback and monitor outcomes. This preemptive approach allows us to continuously improve our products and processes, ensuring our medications remain safe and effective throughout their lifecycle.
Contract Compliance: Upholding Integrity and Safety
Pharmacovigilance is just one part of WPRX’s compliance. Our contract compliance department plays a crucial role in maintaining the integrity of our products and our relationships with partners.
This team also manages complex Medicaid contracts that allow us to provide affordable medications to patients nationwide. With over 180 Medicaid contracts spanning all fifty states, our team works diligently to ensure that all reimbursement claims are accurate and that our products are listed correctly. This meticulous attention to detail ensures we maintain the highest compliance standards to reinforce our partners’ trust.
Why Pharmacies Choose WPRX
We understand that even the smallest oversight in the pharmaceutical industry can have serious consequences. That's why we have built a culture of compliance that permeates every aspect of our operations.
When pharmacies partner with WPRX, they can do so with confidence, knowing that they are working with a company that prioritizes compliance and the well-being of their patients above all else.
We are proud to be compliance champions, providing pharmacies with the peace of mind to focus on what matters most—caring for their patients. Contact us to learn more about how we can expand access to safe, compliant, and effective generic pharmaceuticals together.