MVS Pharma wholesale authorization: Achieving a Wholesale Distribution Authorization (WDA) is a milestone for any pharmaceutical company operating in the European Union. At MVS Pharma GmbH, this accomplishment reflects our commitment to ensuring medicinal products’ safety, quality, and integrity throughout the supply chain. Here’s how we successfully achieved our WDA by implementing the EU Good Distribution Practice (GDP) guidelines (2013/C 343/01).
1. Establishing a Robust Quality Management System (QMS)
The cornerstone of our journey toward WDA was the development and implementation of a robust Quality Management System (QMS). MVS Pharma’s QMS was designed to align with the principles of GDP, encompassing all activities from procurement to delivery. Key steps included:
- Defining Clear 4 Levels of the QM System: We developed comprehensively four levels of the QM System which cover all aspects related to procurement, storage, transportation, complaints, and recalls. Read our article to learn more about “The QMS Pyramid: 4 Document Levels for Pharmaceutical Quality System”.
- Electronic Document Control: A centralized electronic documentation system ensures that all approved and active documents are readily available to every process owner including the MVS Quality Policy, SOPs, Work Instructions, etc.
- Regular Training: Employees across all departments received ongoing training to understand GDP requirements and their roles in maintaining compliance.
2. Appointing a Dedicated Responsible Person (RP)
Compliance with EU GDP guidelines mandates the appointment of a Responsible Person (RP). At MVS Pharma, our RP oversees all activities along with QMR related to distribution to ensure adherence to regulatory requirements. The RP supervises the QMS and Regulatory Affairs, conducts risk assessments, and approves critical operations like product returns and recalls.
Our RP is trained in GDP principles and has extensive experience in pharmaceutical distribution.
3. Optimizing Our Premises and Equipment (MVS Pharma wholesale authorization)
To comply with GDP requirements, MVS Pharma invested significantly in state-of-the-art facilities and equipment. Our warehouse is Temperature-Controlled Storage equipped with advanced temperature monitoring systems to ensure consistent temperature and humidity levels. Moreover, all equipment, including thermometers and data loggers, is routinely calibrated to guarantee accurate readings.
4. Streamlining Operations for Compliance
Operations at MVS Pharma were planned and executed to align with GDP standards. We implemented a rigorous supplier qualification process to ensure the reliability and quality of procured medicinal products. Our distribution network is restricted to Authorized Recipients and Licensed entities only; including pharmacies, hospitals, and other authorized wholesalers. Each batch of product is tracked from receipt to dispatch, ensuring full traceability in the event of a recall.
5. Ensuring Safe Transportation
Transportation is a critical aspect of pharmaceutical distribution, and MVS Pharma leaves no room for error. We have Validated Transport Routes. We have conducted risk assessments and route validations to ensure optimal conditions for product delivery. During transit, Real-time temperature tracking systems were implemented for temperature-sensitive products, and in case of transportation delays or equipment failures; we have developed contingency plans and emergency procedures to address the failure.
6. Establishing a Complaint and Recall System
To meet GDP requirements for handling product complaints, returns, and recalls, we established a complaint management system that records, investigates, and resolves complaints promptly. Moreover, returned goods are quarantined and assessed to determine whether they can be reintroduced into inventory. In the rare event of a recall, predefined steps ensure swift and efficient action to protect patient safety.
7. Conducting Regular Self-Inspections (MVS Pharma wholesale authorization)
To maintain compliance, MVS Pharma conducts regular self-inspections. Our RP and QMR evaluate adherence to GDP guidelines and identify areas for improvement. Any deviations are documented, and corrective measures are implemented promptly.
8. Passing Regulatory Inspections
Our efforts culminated in a successful inspection by regulatory authorities, leading to the granting of our WDA. Inspectors praised our commitment to GDP principles, noting the thoroughness of our QMS, the expertise of our RP and QMR, and the reliability of our operations.
Conclusion for MVS Pharma wholesale authorization
Achieving the WDA is a testament to MVS Pharma’s strong commitment to keeping medicines safe and of high quality. By following the EU GDP guidelines step by step, we’ve proven that we can be trusted to handle and distribute medicines the right way.
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MVS Pharma GmbH will soon be launching an omega-3 dietary supplement onto the European market that has been developed for the highest quality standards in terms of oxidation avoidance and therefore greatest bioavailability. In addition, in vitro studies are currently underway at the University of Ulm, in which Professor Dr. Rüdiger Groß tested a patented mouth and nose spray (Virudol) that can eliminate various flu viruses based on natural substances. In addition, MVS has a wholesale license and has specialized in sourcing much-needed medicines such as Amoxicillin, Salbutamol, etc. from India through its local branch with a focus on local quality and safety testing, compliance with international GMP regulations and the highest quality level of user security (examples of local language brochures, identical units of measurement, batch control and full tracking, etc.).
